Cleared Traditional

CASSETTE EMBOSSEER

K863483 · Surgipath Medical Industries, Inc. · Pathology
Sep 1986
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K863483 is an FDA 510(k) clearance for the CASSETTE EMBOSSEER, a Cassettes, Tissue (Class I — General Controls, product code IDZ), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on September 16, 1986, 7 days after receiving the submission on September 9, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K863483 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1986
Decision Date September 16, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IDZ — Cassettes, Tissue
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010