Cleared Traditional

K913777 - SELF-CONTAINED SURGICAL SLUSH FREEZER
(FDA 510(k) Clearance)

K913777 · Taylor Corp. · Chemistry device

Sep 1991

Decision

42d

Days

Class 1

Risk

K913777 is an FDA 510(k) clearance for the SELF-CONTAINED SURGICAL SLUSH FREEZER. This device is classified as a Freezer (Class I - General Controls, product code JRM).

Submitted by Taylor Corp. (Rockton, US). The FDA issued a Cleared decision on September 25, 1991, 42 days after receiving the submission on August 14, 1991.

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

Submission Details

510(k) Number	K913777 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 14, 1991
Decision Date	September 25, 1991
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement