Cleared Traditional

CONPHAR MAYO HEGAR NEEDLE HOLDER

K821354 · Conphar, Inc. · General & Plastic Surgery
Jun 1982
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K821354 is an FDA 510(k) clearance for the CONPHAR MAYO HEGAR NEEDLE HOLDER, 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, 29 days after receiving the submission on May 5, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K821354 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1982
Decision Date June 03, 1982
Days to Decision 29 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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