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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K121713
Device Name PMT BONE SCREWS
Applicant
PROVIDENCE MEDICAL TECHNOLOGY, INC.
3650 MT Diablo Blvd Ste 104
Lafayette,  CA  94549
Applicant Contact GLEN MANGSETH
Correspondent
PROVIDENCE MEDICAL TECHNOLOGY, INC.
3650 MT Diablo Blvd Ste 104
Lafayette,  CA  94549
Correspondent Contact GLEN MANGSETH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/11/2012
Decision Date 09/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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