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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Vocal Cord Medialization
510(k) Number K983525
Device Name GORE REVOX THYROPLASTY IMPLANT
Applicant
W. L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922
Applicant Contact JOHN NICHOLSON
Correspondent
W. L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922
Correspondent Contact JOHN NICHOLSON
Regulation Number874.3620
Classification Product Code
MIX  
Date Received10/08/1998
Decision Date 12/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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