Cleared Traditional

TISSUE SECTION ADHESIVE

K881659 · Surgipath Medical Industries, Inc. · Pathology
Apr 1988
Decision
6d
Days
Class 1
Risk

About This 510(k) Submission

K881659 is an FDA 510(k) clearance for the TISSUE SECTION ADHESIVE, a Gelatin For Specimen Adhesion (Class I — General Controls, product code IFZ), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on April 21, 1988, 6 days after receiving the submission on April 15, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K881659 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1988
Decision Date April 21, 1988
Days to Decision 6 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IFZ — Gelatin For Specimen Adhesion
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010