Cleared Traditional

K840304 - CATEGORY 17-MICROBIOLOGY DEVICES
(FDA 510(k) Clearance)

K840304 · Imm Enterprises , Ltd. · General & Plastic Surgery

May 1984

Decision

98d

Days

Class 1

Risk

K840304 is an FDA 510(k) clearance for the CATEGORY 17-MICROBIOLOGY DEVICES, a Forceps (Class I — General Controls, product code HTD), submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984, 98 days after receiving the submission on January 24, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K840304 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1984
Decision Date	May 01, 1984
Days to Decision	98 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—