Cleared Traditional

ZENKERS SOLUTION

K842732 · E K Ind., Inc. · Pathology

Aug 1984

Decision

21d

Days

Class 1

Risk

About This 510(k) Submission

K842732 is an FDA 510(k) clearance for the ZENKERS SOLUTION, a Solution, Zenker's (Class I — General Controls, product code IFH), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984, 21 days after receiving the submission on July 13, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K842732 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 1984
Decision Date	August 03, 1984
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—