ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

Probe And Director, Gastro-urology

REGULATORY & MARKETING SERVICES, INC.

The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Orion's Foley Catheterization Kit With Catheter And Bag.

Pre-market Notification Details

Device IDK944379
510k NumberK944379
Device Name:ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG
ClassificationProbe And Director, Gastro-urology
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 CodeFGM  
CFR Regulation Number876.4730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-07
Decision Date1995-02-15

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