ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS

Arthroscope

ACUFEX MICROSURGICAL, INC.

The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Arthroscopic Discectomy Systems.

Pre-market Notification Details

Device IDK941709
510k NumberK941709
Device Name:ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
ClassificationArthroscope
Applicant ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield,  MA  02048
ContactLynne Aronson
CorrespondentLynne Aronson
ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield,  MA  02048
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-06
Decision Date1995-04-14

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