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FDA 510(k) Application Details - K052952
Device Classification Name
Accessories, Catheter, G-U
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510(K) Number
K052952
Device Name
Accessories, Catheter, G-U
Applicant
PHYSICIAN TECHNOLOGIES, INC.
4932 EAST HOLBROOK STREET
ANAHEIM, CA 92807-1154 US
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Contact
RANDALL MAY
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Regulation Number
876.5130
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Classification Product Code
KNY
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More FDA Info for this Product Code
Date Received
10/20/2005
Decision Date
05/14/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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