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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844142
Device Name GORE-TEX TISSUE MATRIX
Applicant
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Applicant Contact JEANNE AMBRUSTER
Correspondent
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Correspondent Contact JEANNE AMBRUSTER
Date Received10/23/1984
Decision Date 06/28/1985
Decision Substantially Equivalent (SESE)
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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