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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K925098
Device Name BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE
Applicant
Bioscience, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Bioscience, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received10/08/1992
Decision Date 07/19/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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