Cleared Traditional

K790549 - HEATING BLOCK, WAMPOLE 37 C
(FDA 510(k) Clearance)

May 1979
Decision
44d
Days
Class 1
Risk

K790549 is an FDA 510(k) clearance for the HEATING BLOCK, WAMPOLE 37 C. This device is classified as a Block, Heating (Class I - General Controls, product code JRG).

Submitted by Armkel, LLC (Mchenry, US). The FDA issued a Cleared decision on May 3, 1979, 44 days after receiving the submission on March 20, 1979.

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

Submission Details

510(k) Number K790549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1979
Decision Date May 03, 1979
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JRG — Block, Heating
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2050