ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE

Catheter, Retention Type, Balloon

REGULATORY & MARKETING SERVICES, INC.

The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Orion All Silicone Foley Catheter Temperature Probe.

Pre-market Notification Details

Device IDK944381
510k NumberK944381
Device Name:ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
ClassificationCatheter, Retention Type, Balloon
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 CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-07
Decision Date1994-11-30

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