INSUFFLATOR TUBING/FILTER KIT

Insufflator, Laparoscopic

O.R. CONCEPTS, INC.

The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Insufflator Tubing/filter Kit.

Pre-market Notification Details

Device IDK922244
510k NumberK922244
Device Name:INSUFFLATOR TUBING/FILTER KIT
ClassificationInsufflator, Laparoscopic
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 CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-13
Decision Date1993-09-24

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