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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 K936216
Device Name STERILE GAUZE SPONGES
Applicant
Dav-Mar Medical Products, Inc.
35 E. Grassy Sprain Rd.
Yonkers,  NY  10710
Applicant Contact STEVEN HERSCH
Correspondent
Dav-Mar Medical Products, Inc.
35 E. Grassy Sprain Rd.
Yonkers,  NY  10710
Correspondent Contact STEVEN HERSCH
Classification Product Code
EFQ  
Date Received12/29/1993
Decision Date 03/09/1994
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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