Cleared Traditional

(MSI) PATH-SAVER

K872140 · Medical Specialties, Inc. · Pathology
Jun 1987
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K872140 is an FDA 510(k) clearance for the (MSI) PATH-SAVER, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on June 15, 1987, 13 days after receiving the submission on June 2, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K872140 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1987
Decision Date June 15, 1987
Days to Decision 13 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IFP — Formalin, Neutral Buffered
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010