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FDA 510(k) Application Details - K970489
Device Classification Name
Dislodger, Stone, Basket, Ureteral, Metal
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510(K) Number
K970489
Device Name
Dislodger, Stone, Basket, Ureteral, Metal
Applicant
COMEG ENDOSCOPY
13790 EAST RICE PLACE
AURORA, CO 80015 US
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Contact
PETER DUFFY
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Regulation Number
876.4680
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Classification Product Code
FFL
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Date Received
02/10/1997
Decision Date
03/19/1997
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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