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FDA 510(k) Application Details - K980588
Device Classification Name
Retractor
More FDA Info for this Device
510(K) Number
K980588
Device Name
Retractor
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
878.4800
More FDA Info for this Regulation Number
Classification Product Code
GAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/17/1998
Decision Date
08/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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