H-H HUNTER ACTIVE TENDON IMPLANT PC

Prosthesis, Tendon, Passive

HOLTER-HAUSNER INTL.

The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Hunter Active Tendon Implant Pc.

Pre-market Notification Details

Device IDK872284
510k NumberK872284
Device Name:H-H HUNTER ACTIVE TENDON IMPLANT PC
ClassificationProsthesis, Tendon, Passive
Applicant HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport,  PA  19405
ContactJohn R Bolles
CorrespondentJohn R Bolles
HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport,  PA  19405
Product CodeHXA  
CFR Regulation Number888.3025 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-16
Decision Date1987-09-28

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