Cleared Traditional

SKIN BIOPSY DEVICE

K933324 · Nhr, Inc. · General & Plastic Surgery

Mar 1994

Decision

262d

Days

Class 1

Risk

About This 510(k) Submission

K933324 is an FDA 510(k) clearance for the SKIN BIOPSY DEVICE, a Device, Percutaneous, Biopsy (Class I — General Controls, product code MJG), submitted by Nhr, Inc. (Monroe, US). The FDA issued a Cleared decision on March 31, 1994, 262 days after receiving the submission on July 12, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K933324 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 1993
Decision Date	March 31, 1994
Days to Decision	262 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement