510(k) K022052

40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 by Northgate Technologies, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2003
Date Received
June 24, 2002
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