FDA 510(k) Application Details - K994418

Device Classification Name Hysteroscope (And Accessories)

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510(K) Number K994418
Device Name Hysteroscope (And Accessories)
Applicant ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
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Contact GREGORY JONES
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Regulation Number 884.1690

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Classification Product Code HIH
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Date Received 12/29/1999
Decision Date 01/24/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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