Cleared Traditional

MACLEAN-FOGG, DISP. BASE MOLD

K831900 · Polymer Technology Corp. · Pathology
Jul 1983
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K831900 is an FDA 510(k) clearance for the MACLEAN-FOGG, DISP. BASE MOLD, a Container, Embedding (Class I — General Controls, product code KER), submitted by Polymer Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983, 44 days after receiving the submission on June 14, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K831900 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1983
Decision Date July 28, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KER — Container, Embedding
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010