CATHASSIST

Accessories, Catheter, G-u

PHYSICIAN TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Physician Technologies, Inc. with the FDA for Cathassist.

Pre-market Notification Details

Device IDK052952
510k NumberK052952
Device Name:CATHASSIST
ClassificationAccessories, Catheter, G-u
Applicant PHYSICIAN TECHNOLOGIES, INC. 4932 EAST HOLBROOK STREET Anaheim,  CA  92807 -1154
ContactRandall May
CorrespondentRandall May
PHYSICIAN TECHNOLOGIES, INC. 4932 EAST HOLBROOK STREET Anaheim,  CA  92807 -1154
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-20
Decision Date2006-05-14

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