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FDA 510(k) Application Details - K003917
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K003917
Device Name
Mesh, Surgical, Polymeric
Applicant
BRIDGER BIOMED, INC.
2430 NORTH 7TH AVE., SUITE 4
BOZEMAN, MT 59715 US
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Contact
BRUCE G RUEFER
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
12/19/2000
Decision Date
01/26/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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