Cleared Traditional

DECALCIFIER I

K841488 · Surgipath Medical Industries, Inc. · Pathology
May 1984
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K841488 is an FDA 510(k) clearance for the DECALCIFIER I, a Solution, Decalcifier, Acid Containing (Class I — General Controls, product code KDX), submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984, 22 days after receiving the submission on April 10, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K841488 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1984
Decision Date May 02, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KDX — Solution, Decalcifier, Acid Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010