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FDA 510(k) Application Details - K963653
Device Classification Name
Electrocautery, Gynecologic (And Accessories)
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510(K) Number
K963653
Device Name
Electrocautery, Gynecologic (And Accessories)
Applicant
WALLACH SURGICAL DEVICES, INC.
291 PEPE'S FARM RD.
MILFORD, CT 06460 US
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Contact
RAYMOND A WILEY
Other 510(k) Applications for this Contact
Regulation Number
884.4120
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Classification Product Code
HGI
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More FDA Info for this Product Code
Date Received
09/12/1996
Decision Date
06/11/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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