LOWSLEY SUPRAPUBIC TRACTOR

Catheter, Suprapubic (and Accessories)

CIRCON VIDEO

The following data is part of a premarket notification filed by Circon Video with the FDA for Lowsley Suprapubic Tractor.

Pre-market Notification Details

Device IDK012153
510k NumberK012153
Device Name:LOWSLEY SUPRAPUBIC TRACTOR
ClassificationCatheter, Suprapubic (and Accessories)
Applicant CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara,  CA  93117 -3019
ContactWayne B Stgrner
CorrespondentWayne B Stgrner
CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara,  CA  93117 -3019
Product CodeKOB  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-11
Decision Date2001-09-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925005204 K012153 000
00821925005082 K012153 000

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