O.R. CONCEPTS' IRRIGATING KITTNER

Carrier, Sponge, Endoscopic

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' Irrigating Kittner.

Pre-market Notification Details

Device IDK923818
510k NumberK923818
Device Name:O.R. CONCEPTS' IRRIGATING KITTNER
ClassificationCarrier, Sponge, Endoscopic
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 CodeFGS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-30
Decision Date1993-04-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.