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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 K131657
Device Name FLOWER SMALL AND MEDIUM IMPLANT SET
Applicant
Flower Orthopedics Corporation
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
Flower Orthopedics Corporation
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/06/2013
Decision Date 08/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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