Cleared Traditional

K782077 - LANCER ICE CUBE
(FDA 510(k) Clearance)

K782077 · Sherwood Medical Industries · Pathology

Apr 1979

Decision

111d

Days

Class 1

Risk

K782077 is an FDA 510(k) clearance for the LANCER ICE CUBE. This device is classified as a Freezer (Class I — General Controls, product code JRM).

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979, 111 days after receiving the submission on December 13, 1978.

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

Submission Details

510(k) Number	K782077 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 13, 1978
Decision Date	April 03, 1979
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—