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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 K003917
Device Name MODIFICATION TO FLUOROTEX II 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 Received12/19/2000
Decision Date 01/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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