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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K133930
Device Name FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
Applicant
Flower Orthopedics Corporation
100 Witmer Rd.
Suite 280
Horsham,  PA  19044
Applicant Contact GARY BARNETT
Correspondent
Flower Orthopedics Corporation
100 Witmer Rd.
Suite 280
Horsham,  PA  19044
Correspondent Contact GARY BARNETT
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/23/2013
Decision Date 03/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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