Cleared Traditional

K946162 - 3M(TM) SURGICAL SLIPPER, 9660 SERIES
(FDA 510(k) Clearance)

Jan 1995
Decision
36d
Days
Class 1
Risk

K946162 is an FDA 510(k) clearance for the 3M(TM) SURGICAL SLIPPER, 9660 SERIES. This device is classified as a Razor, Surgical (Class I - General Controls, product code LWK).

Submitted by Wahl Clipper Corp. (Steriling, US). The FDA issued a Cleared decision on January 24, 1995, 36 days after receiving the submission on December 19, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K946162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date January 24, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LWK — Razor, Surgical
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800