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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 K950462
Device Name GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)
Applicant
Spring Intl., Inc.
917 Knottingham Dr., Unit 2a
Schaumburg,  IL  60193
Applicant Contact SHUN-YEE TANG
Correspondent
Spring Intl., Inc.
917 Knottingham Dr., Unit 2a
Schaumburg,  IL  60193
Correspondent Contact SHUN-YEE TANG
Classification Product Code
EFQ  
Date Received02/03/1995
Decision Date 04/14/1995
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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