Cleared Traditional

ROUND-BEEHIVE- DISSECTORS 3/8

K831912 · Ormed Mfg., Inc. · General & Plastic Surgery
Oct 1983
Decision
139d
Days
Class 1
Risk

About This 510(k) Submission

K831912 is an FDA 510(k) clearance for the ROUND-BEEHIVE- DISSECTORS 3/8, a Dissector, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDI), submitted by Ormed Mfg., Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983, 139 days after receiving the submission on June 14, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K831912 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1983
Decision Date October 31, 1983
Days to Decision 139 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDI — Dissector, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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