Cleared Traditional

KNIFE MAKER

K863616 · Surgipath Medical Industries, Inc. · Pathology
Sep 1986
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K863616 is an FDA 510(k) clearance for the KNIFE MAKER, a Microtome, Accessories (Class I — General Controls, product code IDL), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on September 25, 1986, 9 days after receiving the submission on September 16, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K863616 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1986
Decision Date September 25, 1986
Days to Decision 9 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