Cleared Traditional

MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8

K873391 · Ormed Mfg., Inc. · General & Plastic Surgery

Sep 1987

Decision

18d

Days

Class 1

Risk

About This 510(k) Submission

K873391 is an FDA 510(k) clearance for the MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on September 11, 1987, 18 days after receiving the submission on August 24, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.

Submission Details

510(k) Number	K873391 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 1987
Decision Date	September 11, 1987
Days to Decision	18 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—