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FDA 510(k) Application Details - K962653
Device Classification Name
Electrode, Electrosurgical, Active, Urological
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510(K) Number
K962653
Device Name
Electrode, Electrosurgical, Active, Urological
Applicant
MICROGYN CORP.
125 JOHN HANCOCK RD.
TAUNTON, MA 02780 US
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Contact
CRAIG TRAUB
Other 510(k) Applications for this Contact
Regulation Number
876.4300
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Classification Product Code
FAS
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More FDA Info for this Product Code
Date Received
07/08/1996
Decision Date
02/04/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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