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510(k) K973447

OMNIFLATOR 6630(6-630-00) by Northgate Technologies, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1998
Date Received
September 11, 1997
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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