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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 K123562
Device Name FLOWER SMALL AND MEDIUM BONE IMPLANTS
Applicant
FLOWER ORTHOPEDICS CORPORATION
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
FLOWER ORTHOPEDICS CORPORATION
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/19/2012
Decision Date 03/29/2013
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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