O.R. CONCEPTS' ELECTROSURGICAL PROBE

Electrosurgical, Cutting & Coagulation & Accessories

O.R. CONCEPTS, INC.

The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for O.r. Concepts' Electrosurgical Probe.

Pre-market Notification Details

Device IDK923416
510k NumberK923416
Device Name:O.R. CONCEPTS' ELECTROSURGICAL PROBE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
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 CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-10
Decision Date1992-11-20

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