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FDA 510(k) Application Details - K031789
Device Classification Name
Endoscopic Ultrasound System, Gastroenterology-Urology
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510(K) Number
K031789
Device Name
Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG, NY 10962 US
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Contact
PAUL SILVA
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Regulation Number
876.1500
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Classification Product Code
ODG
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More FDA Info for this Product Code
Date Received
06/10/2003
Decision Date
08/08/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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