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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 K935241
Device Name GAUZE DRESSING
Applicant
Chak Tak (Shen Zhen) Enterprises, Ltd.
1688 Glen Ellyn Rd.
Glendale Hts.,  IL  60139
Applicant Contact DAVID INSCO
Correspondent
Chak Tak (Shen Zhen) Enterprises, Ltd.
1688 Glen Ellyn Rd.
Glendale Hts.,  IL  60139
Correspondent Contact DAVID INSCO
Classification Product Code
EFQ  
Date Received11/01/1993
Decision Date 01/25/1994
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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