O.R. CONCEPTS CABLE HARNESS

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 Cable Harness.

Pre-market Notification Details

Device IDK924264
510k NumberK924264
Device Name:O.R. CONCEPTS CABLE HARNESS
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 Received1992-08-24
Decision Date1992-09-11

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