Cleared Traditional

DISPOSABLE MICROTOME BLADE

K831308 · Surgipath Medical Industries, Inc. · Pathology
May 1983
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K831308 is an FDA 510(k) clearance for the DISPOSABLE MICROTOME BLADE, a Microtome, Accessories (Class I — General Controls, product code IDL), submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983, 24 days after receiving the submission on April 22, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K831308 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1983
Decision Date May 16, 1983
Days to Decision 24 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