FASTUBE NERVE REGENERATION DEVICE

Cuff, Nerve

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Fastube Nerve Regeneration Device.

Pre-market Notification Details

Device IDK850785
510k NumberK850785
Device Name:FASTUBE NERVE REGENERATION DEVICE
ClassificationCuff, Nerve
Applicant RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
ContactMichael N Kelly
CorrespondentMichael N Kelly
RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
Product CodeJXI  
CFR Regulation Number882.5275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-26
Decision Date1985-07-10

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