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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 K881395
Device Name GAUZE AND LAP SPONGES -STERILE & NON-STERILE
Applicant
A Plus International, Inc.
275 S. 3rd Ave.
#2
La Puente,  CA  91746
Applicant Contact DAVID S LEE
Correspondent
A Plus International, Inc.
275 S. 3rd Ave.
#2
La Puente,  CA  91746
Correspondent Contact DAVID S LEE
Classification Product Code
EFQ  
Date Received04/04/1988
Decision Date 04/28/1988
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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