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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Orthopedic
510(k) Number K853436
Device Name H-H HUNTER PASSIVE TENDON IMPLANT
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 Number878.4800
Classification Product Code
HXR  
Date Received08/15/1985
Decision Date 10/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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