(344 days)
A vapocoolant intended for topical application in management of myofacial pain, restricted motion, and muscle spasm, and for the control of pain associated with injections, minor surgical procedures and the temporary relief of minor sports injuries.
Dispenser Containing a Vapocoolant
This document does not contain information about the acceptance criteria and the study proving the device meets them. The provided text is a 510(k) summary for an Ethyl Chloride and Dispenser and the FDA's response regarding its substantial equivalence to a predicate device.
It includes:
- Contact information for the submitter.
- Date of the summary.
- Trade name, classification, and predicate device.
- Device description and intended use.
- FDA's letter of substantial equivalence.
- Detailed indications for use.
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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| DEC | 2 |
|---|---|
| 1999 |
K19845564
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)3234 Ella LaneNew Port Richey, FL 34655 | |
|---|---|---|
| Phone:Fax: | 727-376-4154727-376-7186 | |
| Contact Person: | Ed Ransom or Pat Lamb | |
| Date of Summary: | December 2,,1999 | |
| Trade Name: | Ethyl Chloride and Dispenser | |
| Classification Name: | Unknown | |
| Predicate Device: | Gebauer Fluori-Methane | |
| Device Description/Comparison: | Dispenser Containing a Vapocoolant | |
| Intended Use: | A vapocoolant intended for topical application inmanagement of myofacial pain, restricted motion, andmuscle spasm, and for the control of pain associatedwith injections, minor surgical procedures and thetemporary relief of minor sports injuries. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Mr. Ed Ransom Consultant Regulatory and Marketing Services, Inc. Representing Dukal Corporation P.O. Box 1108 Elfers, Florida 34680
Re : K984564 Ethyl Chloride Dispenser Trade Name: Unclassified Regulatory Class: Product Code: MLY September 2, 1999 Dated: September 3, 1999 Received:
Dear Mr. Ransom:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ed Ransom
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N. Milkerse
Dillard III James E. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Ethyl Chloride Spray
Indications For Use:
A vapocoolant intended for topical application in management of myofacial pain, restricted motion, and muscle spasm, and for the control of pain associated with injections, minor surgical procedures and the temporary relief of minor sports injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milberson
fr
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K984564
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
N/A