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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K984197
Device Name FLUOROTEX SURGICAL MESH
Applicant
BRIDGER BIOMED, INC.
2430 NORTH 7TH AVE., SUITE 4
BOZEMAN,  MT  59715
Applicant Contact BRUCE G RUEFER
Correspondent
BRIDGER BIOMED, INC.
2430 NORTH 7TH AVE., SUITE 4
BOZEMAN,  MT  59715
Correspondent Contact BRUCE G RUEFER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/23/1998
Decision Date 01/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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