INSTRUMENTS NONSTERILE & STERILE

Instrument, Surgical, Non-powered

ASCEP, INC.

The following data is part of a premarket notification filed by Ascep, Inc. with the FDA for Instruments Nonsterile & Sterile.

Pre-market Notification Details

Device IDK802726
510k NumberK802726
Device Name:INSTRUMENTS NONSTERILE & STERILE
ClassificationInstrument, Surgical, Non-powered
Applicant ASCEP, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHAO  
CFR Regulation Number882.4535 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-27
Decision Date1980-11-19

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