Cleared Traditional

HESSBURG-BFRRON TREPHINE

K801585 · Precision Instruments, Inc. · General & Plastic Surgery
Oct 1980
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K801585 is an FDA 510(k) clearance for the HESSBURG-BFRRON TREPHINE, a Knife, Surgical (Class I — General Controls, product code EMF), submitted by Precision Instruments, Inc.. The FDA issued a Cleared decision on October 3, 1980, 84 days after receiving the submission on July 11, 1980. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K801585 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1980
Decision Date October 03, 1980
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code EMF — Knife, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800