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FDA 510(k) Application Details - K971146
Device Classification Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
More FDA Info for this Device
510(K) Number
K971146
Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant
RD CHUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
ROSINA ROBINSON
Other 510(k) Applications for this Contact
Regulation Number
884.4160
More FDA Info for this Regulation Number
Classification Product Code
KNF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/28/1997
Decision Date
08/25/1997
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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