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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tendon, Passive
510(k) Number K872284
Device Name H-H HUNTER ACTIVE TENDON IMPLANT PC
Applicant
Holter-Hausner Intl.
Third And Mill St.s
P.O. Box 100
Bridgeport,  PA  19405
Applicant Contact JOHN R BOLLES
Correspondent
Holter-Hausner Intl.
Third And Mill St.s
P.O. Box 100
Bridgeport,  PA  19405
Correspondent Contact JOHN R BOLLES
Regulation Number888.3025
Classification Product Code
HXA  
Date Received06/16/1987
Decision Date 09/28/1987
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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