510(k) K922777

PRESSURE TUBING AND ACCESSORIES by Arbor Technologies, Inc. — Product Code HIF

K922777 is an FDA 510(k) premarket notification submitted by Arbor Technologies, Inc. for the device "PRESSURE TUBING AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Arbor Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1994
Date Received
June 9, 1992
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