FDA 510(k) Application Details - K123365

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K123365
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY, PA 18034-0610 US
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Contact SHERI L MUSGNUNG
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 10/31/2012
Decision Date 03/01/2013
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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