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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 K991215
Device Name SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
Applicant
Symtex Healthcare Corp.
783 Pinefalls Ave.
Walnut,  CA  91789
Applicant Contact RICHARD S WANG
Correspondent
Symtex Healthcare Corp.
783 Pinefalls Ave.
Walnut,  CA  91789
Correspondent Contact RICHARD S WANG
Classification Product Code
EFQ  
Date Received04/09/1999
Decision Date 06/11/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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