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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
Model PD-30-A-BB
Device Name PMT BONE SCREWS
Applicant
PROVIDENCE MEDICAL TECHNOLOGY, INC.
3650 mt diablo blvd ste 104
lafayette,  CA  94549
Contact glen mangseth
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/11/2012
Decision Date 09/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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