Cleared Traditional

K841741 - SINGLE HAIR TRANSPLANT GRAFT (FDA 510(k) Clearance)

Jul 1984
Decision
91d
Days
Class 1
Risk

K841741 is an FDA 510(k) clearance for the SINGLE HAIR TRANSPLANT GRAFT. This device is classified as a Cutter, Surgical (Class I - General Controls, product code FZT).

Submitted by Paris Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 23, 1984, 91 days after receiving the submission on April 23, 1984.

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

Submission Details

510(k) Number K841741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date July 23, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FZT — Cutter, Surgical
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800

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