Cleared Traditional

K821283 - HARTMAN FORCEPS (MOSQUITO)
(FDA 510(k) Clearance)

May 1982
Decision
24d
Days
Class 1
Risk

K821283 is an FDA 510(k) clearance for the HARTMAN FORCEPS (MOSQUITO). This device is classified as 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 27, 1982, 24 days after receiving the submission on May 3, 1982.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K821283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date May 27, 1982
Days to Decision 24 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