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FDA 510(k) Application Details - K955618
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K955618
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER, IN 47460 US
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Contact
TAMMY BACON
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
12/11/1995
Decision Date
01/22/1996
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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