Cleared Traditional

ROCHESTER PEAN FORCEPS

K821248 · Conphar, Inc. · General & Plastic Surgery
May 1982
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K821248 is an FDA 510(k) clearance for the ROCHESTER PEAN FORCEPS, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 25 days after receiving the submission on May 3, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K821248 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1982
Decision Date May 28, 1982
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800