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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K052952
Device Name CATHASSIST
Applicant
PHYSICIAN TECHNOLOGIES, INC.
4932 EAST HOLBROOK STREET
ANAHEIM,  CA  92807 -1154
Applicant Contact RANDALL MAY
Correspondent
PHYSICIAN TECHNOLOGIES, INC.
4932 EAST HOLBROOK STREET
ANAHEIM,  CA  92807 -1154
Correspondent Contact RANDALL MAY
Regulation Number876.5130
Classification Product Code
KNY  
Date Received10/20/2005
Decision Date 05/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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