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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Synthetic Wound Dressing
510(k) Number K132397
Device Name GORE BIO-A WOUND MATRIX
Applicant
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21921
Applicant Contact BARBARA L SMITH, RAC
Correspondent
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21921
Correspondent Contact BARBARA L SMITH, RAC
Classification Product Code
QSZ  
Date Received08/01/2013
Decision Date 05/07/2014
Decision Substantially Equivalent (SESE)
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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