Cleared Traditional

LANCER PARAPLAST HISTO PROCESS CASSETTE

K760623 · Sherwood Medical Industries · Pathology
Sep 1976
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K760623 is an FDA 510(k) clearance for the LANCER PARAPLAST HISTO PROCESS CASSETTE, a Cassettes, Tissue (Class I — General Controls, product code IDZ), submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on September 27, 1976, 14 days after receiving the submission on September 13, 1976. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K760623 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1976
Decision Date September 27, 1976
Days to Decision 14 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