THERMALAP

Drape, Surgical

O.R. CONCEPTS, INC.

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

Pre-market Notification Details

Device IDK893212
510k NumberK893212
Device Name:THERMALAP
ClassificationDrape, Surgical
Applicant O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
ContactJoe A Staley
CorrespondentJoe A Staley
O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-27
Decision Date1989-06-01

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