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FDA 510(k) Application Details - K971202
Device Classification Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
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510(K) Number
K971202
Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant
COMEG ENDOSKOPIE GMBH
13790 E. RICE PLACE
AURORA, CO 80015 US
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Contact
PETER DUFFY
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCZ
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More FDA Info for this Product Code
Date Received
04/01/1997
Decision Date
05/27/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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