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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K800021
Device Name NON ADHERANT NEUROLOGICAL SPONGES
Applicant
American Medical Disposable, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Medical Disposable, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
EFQ  
Date Received01/04/1980
Decision Date 01/17/1980
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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