Cleared Traditional

SUCTION/IRRIGATOR TUBING KIT

K952605 · Surgical Laser Technologies, Inc. · General Hospital
Sep 1995
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K952605 is an FDA 510(k) clearance for the SUCTION/IRRIGATOR TUBING KIT, a Tubing, Noninvasive (Class II — Special Controls, product code GAZ), submitted by Surgical Laser Technologies, Inc. (Oaks, US). The FDA issued a Cleared decision on September 15, 1995, 101 days after receiving the submission on June 6, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K952605 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1995
Decision Date September 15, 1995
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code GAZ — Tubing, Noninvasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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