FDA 510(k) Application Details - K061050

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K061050
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE, NJ 08876 US
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Contact BRYAN LISA
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 04/17/2006
Decision Date 07/14/2006
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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