ACUFEX SMOOTH AND THREADED PINS

Pin, Fixation, Smooth

ACUFEX MICROSURGICAL, INC.

The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Smooth And Threaded Pins.

Pre-market Notification Details

Device IDK931836
510k NumberK931836
Device Name:ACUFEX SMOOTH AND THREADED PINS
ClassificationPin, Fixation, Smooth
Applicant ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield,  MA  02048
ContactLynne Aronson
CorrespondentLynne Aronson
ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield,  MA  02048
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-13
Decision Date1994-06-28

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