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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853437
Device Name H-H HUNTER TENDON ROD
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
Date Received08/15/1985
Decision Date 10/16/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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