Cleared Traditional

DISPOSABLE MICROTOME BLADES

K831921 · Polymer Technology Corp. · Pathology
Jul 1983
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K831921 is an FDA 510(k) clearance for the DISPOSABLE MICROTOME BLADES, a Microtome, Accessories (Class I — General Controls, product code IDL), submitted by Polymer Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on July 29, 1983, 45 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 K831921 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1983
Decision Date July 29, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IDL — Microtome, Accessories
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010