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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Surgical, Internal
510(k) Number K900195
Device Name MODIFIED GORE-TEX SURGICAL TAPE
Applicant
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Applicant Contact CRAIG NEWMAN
Correspondent
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Correspondent Contact CRAIG NEWMAN
Regulation Number878.3300
Classification Product Code
MCA  
Date Received01/11/1990
Decision Date 03/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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