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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K980548
Device Name DURA-PATCH MODEL DP-XXX
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 Number882.5910
Classification Product Code
GXQ  
Date Received02/12/1998
Decision Date 05/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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