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FDA 510(k) Application Details - K971838
Device Classification Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
More FDA Info for this Device
510(K) Number
K971838
Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant
COOPERSURGICAL, INC.
15 FOREST PKWY.
SHELTON, CT 06484 US
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Contact
DEBRA A PEKAR
Other 510(k) Applications for this Contact
Regulation Number
884.4160
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Classification Product Code
KNF
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More FDA Info for this Product Code
Date Received
05/19/1997
Decision Date
11/05/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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