Cleared Traditional

DISPOSABLE BASE MOLD

K831335 · Surgipath Medical Industries, Inc. · Pathology
May 1983
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K831335 is an FDA 510(k) clearance for the DISPOSABLE BASE MOLD, a Container, Embedding (Class I — General Controls, product code KER), submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983, 21 days after receiving the submission on April 25, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K831335 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1983
Decision Date May 16, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KER — Container, Embedding
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010