(116 days)
Non-surgical closure of nasal septum perforation
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Nasal Septal Button" by Micromedics, Inc. It states that the device is substantially equivalent to a pre-amendment device and can be marketed.
Crucially, this document does NOT contain any information regarding acceptance criteria or the results of a study to prove device performance.
The letter is a regulatory clearance document, not a performance study report. It indicates that the device is cleared for non-surgical closure of nasal septum perforation based on substantial equivalence to devices marketed prior to May 28, 1976. This substantial equivalence determination means the FDA did not require a new clinical study to establish safety and effectiveness for this type of device.
Therefore, I cannot provide the requested information because it is not present in the provided text.
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Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 24 19988
Charles K. Grote Manager of Quality Assurance And Regulatory Affairs Micromedics, Inc. 1285 Corporate Center Drive Eagan, MN 55121
K982667 Nasal Septal Button Dated: November 2, 1998 Received: November 3, 1998 Regulatory class: Unclassified Procode: 77 LFB
Dear Mr. Grote:
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 of the Act. The general controls provisions 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. A substantially equivalent decemination assumes compliance with the Current Good Manufacturing Practice requirements, 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 action. In addition, FDA may publish further announcements 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.
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 vitn diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmardsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number: | K982667 | |
|---|---|---|
| Device Name: | Micromedics Inc., Nasal Septal Button | |
| Indications for Use: | Non-surgical closure of nasal septum perforation |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982467
Prescription Use
(Per 21 CFT 801.109)
Indications for Use:
OR
Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________
N/A