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FDA 510(k) Application Details - K110294
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K110294
Device Name
Insufflator, Laparoscopic
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY, PA 18034-0610 US
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Contact
STACY ABBATIELLO KLUESNER
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Regulation Number
884.1730
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Classification Product Code
HIF
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More FDA Info for this Product Code
Date Received
02/01/2011
Decision Date
11/18/2011
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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