(75 days)
The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.
Not Found
This document is a 510(k) premarket notification approval letter from the FDA for a device described as "Water Filled Gum Soother" and "Teething Ring - Water Filled." It is an approval letter for marketing the device based on substantial equivalence to a legally marketed predicate device, not a study. Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The provided text does not contain any data related to device performance studies or acceptance criteria. It is an FDA clearance letter for a medical device ("Water Filled Gum Soother" / "Teething Ring - Water Filled") based on substantial equivalence.
Therefore, I cannot provide the requested information.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TUN 1 6 1998
Mr. Joseph Hakim ·Contract Manufacturing, Incorporated P.O. Box 4084 Monroe, Louisiana 71211
Re : K981202 Trade Name: Water Filled Gum Soother Requlatory Class: II Product Code: KKO Dated: March 23, 1998 Received: April 2, 1998
Dear Mr. Hakim:
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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent-determination 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 GM regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Hakim
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
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Image /page/2/Picture/0 description: The image shows the logo for Contract Manufacturing, Inc. The text is in a bold, sans-serif font. The word "Contract" is on the top line, and the word "Manufacturing" is on the second line. The word "Inc." is on the third line, to the right of the word "Manufacturing."
INDICATIONS FOR USE
,
510(k) Number: K981202 _______________________________________________________________________________________________________________________________________________________
Device Name: Teething Ring - Water Filled
Indications For Use:
: 上一
The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.
" | 房
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DRRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K981202 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use ______ |
|---|---|---|
| (Per 21 CFR 801.109) | -6- | (Optional Format 1-2-96) |
§ 872.5550 Teething ring.
(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.