ORC TAPPERED IRRIGATING PROBE

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

O.R. CONCEPTS, INC.

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

Pre-market Notification Details

Device IDK925024
510k NumberK925024
Device Name:ORC TAPPERED IRRIGATING PROBE
ClassificationApparatus, Suction, Single Patient Use, Portable, Nonpowered
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 CodeGCY  
CFR Regulation Number878.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-02
Decision Date1993-05-21

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