Cleared Traditional

K790993 - INSTANT HOT & COLD PACKS
(FDA 510(k) Clearance)

Sep 1979
Decision
101d
Days
Class 1
Risk

K790993 is an FDA 510(k) clearance for the INSTANT HOT & COLD PACKS. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).

Submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1979, 101 days after receiving the submission on May 29, 1979.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number K790993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1979
Decision Date September 07, 1979
Days to Decision 101 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IMD — Pack, Hot Or Cold, Disposable
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.5710

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