510(k) K952605

SUCTION/IRRIGATOR TUBING KIT by Surgical Laser Technologies, Inc. — Product Code GAZ

K952605 is an FDA 510(k) premarket notification submitted by Surgical Laser Technologies, Inc. for the device "SUCTION/IRRIGATOR TUBING KIT". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Surgical Laser Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
June 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type