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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,Nonresorbable For External Use
510(k) Number K923602
Device Name ABSORBENT PAD -- MODIFICATION
Applicant
Winfield Laboratories, Inc.
1303 Columbia
Suite 207
Richardson,  TX  75081
Applicant Contact GARY W CUMMINGS
Correspondent
Winfield Laboratories, Inc.
1303 Columbia
Suite 207
Richardson,  TX  75081
Correspondent Contact GARY W CUMMINGS
Regulation Number878.4014
Classification Product Code
NAB  
Date Received07/15/1992
Decision Date 12/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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