ORC ENDOSCOPIC INSTRUMENT HOLDER

Instrument, Manual, Surgical, General Use

O.R. CONCEPTS, INC.

The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Orc Endoscopic Instrument Holder.

Pre-market Notification Details

Device IDK930399
510k NumberK930399
Device Name:ORC ENDOSCOPIC INSTRUMENT HOLDER
ClassificationInstrument, Manual, Surgical, General Use
Applicant O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
ContactJohn Mayall
CorrespondentJohn Mayall
O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
Product CodeMDM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-26
Decision Date1993-02-17

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