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FDA 510(k) Application Details - K952030
Device Classification Name
Electrocautery, Gynecologic (And Accessories)
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510(K) Number
K952030
Device Name
Electrocautery, Gynecologic (And Accessories)
Applicant
E & M ENGINEERING, INC.
P.O. BOX 11349
2116 DABNEY ROAD, SUITE A-5
RICHMOND, VA 23230 US
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Contact
WINNY CHOW
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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
05/01/1995
Decision Date
07/31/1996
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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