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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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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