LAPAROSCOPIC SUCTION/IRRIGATION PROBE

Catheter, Cholangiography

O.R. CONCEPTS, INC.

The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Laparoscopic Suction/irrigation Probe.

Pre-market Notification Details

Device IDK920643
510k NumberK920643
Device Name:LAPAROSCOPIC SUCTION/IRRIGATION PROBE
ClassificationCatheter, Cholangiography
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 CodeGBZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-12
Decision Date1992-05-06

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