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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K931094
Device Name PROCEL(TM) DERMALINER GLOVE
Applicant
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86003
Applicant Contact LARRY J KOVACH
Correspondent
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86003
Correspondent Contact LARRY J KOVACH
Regulation Number878.4040
Classification Product Code
LYU  
Date Received03/03/1993
Decision Date 02/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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