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510(k) K014166

UHI-3 HIGH FLOW INSUFFLATION UNIT by Olympus Optical Co., Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2002
Date Received
December 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

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