Cleared Traditional

K894006 - SANISERV SURGICAL SLUSH SYSTEM
(FDA 510(k) Clearance)

K894006 · Saniserv, Inc. · Physical Medicine device

Nov 1989

Decision

151d

Days

Class 1

Risk

K894006 is an FDA 510(k) clearance for the SANISERV SURGICAL SLUSH SYSTEM. This device is classified as a Freezer (Class I - General Controls, product code JRM).

Submitted by Saniserv, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 3, 1989, 151 days after receiving the submission on June 5, 1989.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K894006 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 05, 1989
Decision Date	November 03, 1989
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—