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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 K911378
Device Name TOWNLEY GREAT TOE JOINT
Applicant
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Applicant Contact MICHAEL G GORMAN
Correspondent
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Correspondent Contact MICHAEL G GORMAN
Regulation Number888.3730
Classification Product Code
KWD  
Date Received03/28/1991
Decision Date 11/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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