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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K973538
Device Name N-TERFACE
Applicant
Winfield Laboratories, Inc.
10488 Brockwood Rd.
Dallas,  TX  75238
Applicant Contact GARY W CUMMINGS
Correspondent
Winfield Laboratories, Inc.
10488 Brockwood Rd.
Dallas,  TX  75238
Correspondent Contact GARY W CUMMINGS
Classification Product Code
MGP  
Date Received09/18/1997
Decision Date 12/16/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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