Cleared Traditional

K923627 - COLD PACK
(FDA 510(k) Clearance)

K923627 · Friendmed Products · Physical Medicine device

Apr 1993

Decision

267d

Days

Class 1

Risk

K923627 is an FDA 510(k) clearance for the COLD PACK. This device is classified as a Pack, Hot Or Cold, Reusable (Class I - General Controls, product code IME).

Submitted by Friendmed Products (Athens, US). The FDA issued a Cleared decision on April 14, 1993, 267 days after receiving the submission on July 21, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5700.

Submission Details

510(k) Number	K923627 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 21, 1992
Decision Date	April 14, 1993
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement