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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 K953501
Device Name ADI STERILE GAUZE SPONGES
Applicant
Asia Dynamics, Inc.
5745 W. Howard St.
Niles,  IL  60714
Applicant Contact CHRISTI GERARD
Correspondent
Asia Dynamics, Inc.
5745 W. Howard St.
Niles,  IL  60714
Correspondent Contact CHRISTI GERARD
Classification Product Code
EFQ  
Date Received07/26/1995
Decision Date 08/28/1995
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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