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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K994032
Device Name FLUORO-TEX CARDIOVASCULAR PATCH
Applicant
Bridger Biomed, Inc.
2430 N 7th Ave., Suite 4
Bozeman,  MT  59715
Applicant Contact BRUCE G RUEFER
Correspondent
Bridger Biomed, Inc.
2430 N 7th Ave., Suite 4
Bozeman,  MT  59715
Correspondent Contact BRUCE G RUEFER
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received11/26/1999
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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