ORION RED URETHRAL CATHETER

Catheter, Straight

REGULATORY & MARKETING SERVICES, INC.

The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Orion Red Urethral Catheter.

Pre-market Notification Details

Device IDK944383
510k NumberK944383
Device Name:ORION RED URETHRAL CATHETER
ClassificationCatheter, Straight
Applicant REGULATORY & MARKETING SERVICES, INC. 1247 FLORIDA AVE. Palm Harbor,  FL  34682
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
REGULATORY & MARKETING SERVICES, INC. 1247 FLORIDA AVE. Palm Harbor,  FL  34682
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-07
Decision Date1994-12-06

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