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FDA 510(k) Application Details - K971455
Device Classification Name
Lamp, Endoscope, Incandescent
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510(K) Number
K971455
Device Name
Lamp, Endoscope, Incandescent
Applicant
CLARUS MEDICAL SYSTEMS, INC.
1000 BOONE AVENUE NORTH
#100
MINNEAPOLIS, MN 55427-8656 US
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Contact
DALE SAPPENFIELD
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FTI
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More FDA Info for this Product Code
Date Received
04/21/1997
Decision Date
05/20/1997
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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