H-H HUNTER ACTIVE TENDON IMPLANT

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.

Pre-market Notification Details

Device IDK853438
510k NumberK853438
Device Name:H-H HUNTER ACTIVE TENDON IMPLANT
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 Received1985-08-15
Decision Date1985-09-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.