Cleared Traditional

OLSEN HEGAR NEEDLE HOLDERS

K821295 · Conphar, Inc. · General & Plastic Surgery
Jun 1982
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K821295 is an FDA 510(k) clearance for the OLSEN HEGAR NEEDLE HOLDERS, a Guide, Needle, Surgical (Class I — General Controls, product code GDF), submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982, 30 days after receiving the submission on May 4, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K821295 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1982
Decision Date June 03, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDF — Guide, Needle, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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