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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, toe, hemi-, phalangeal
510(k) Number K121973
Device Name BIOPRO HEMI-EDGE TOE SYSTEM
Applicant
BIOPRO, INC.
3150 E. 200TH ST
PRIOR LAKE,  MN  55372
Applicant Contact AL LIPPINCOTT
Correspondent
BIOPRO, INC.
3150 E. 200TH ST
PRIOR LAKE,  MN  55372
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3730
Classification Product Code
KWD  
Date Received07/05/2012
Decision Date 10/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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