CATHETER, INTRAUTERINE AND INTRODUCER

Monitor, Pressure, Intrauterine

TELOS MEDICAL CORP.

The following data is part of a premarket notification filed by Telos Medical Corp. with the FDA for Catheter, Intrauterine And Introducer.

Pre-market Notification Details

Device IDK883832
510k NumberK883832
Device Name:CATHETER, INTRAUTERINE AND INTRODUCER
ClassificationMonitor, Pressure, Intrauterine
Applicant TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE,  CA  91786
ContactTIMOTHY J TALCOTT
CorrespondentTIMOTHY J TALCOTT
TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE,  CA  91786
Product CodeKXO  
CFR Regulation Number884.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-09
Decision Date1988-12-13

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