Cleared Traditional

K874234 - SURGICAL PREP RAZOR, STRAIGHT TYPE
(FDA 510(k) Clearance)

K874234 · Derma-Safe Co. · General & Plastic Surgery device

Nov 1987

Decision

18d

Days

Class 1

Risk

K874234 is an FDA 510(k) clearance for the SURGICAL PREP RAZOR, STRAIGHT TYPE. This device is classified as a Razor, Surgical (Class I - General Controls, product code LWK).

Submitted by Derma-Safe Co. (Wayne, US). The FDA issued a Cleared decision on November 2, 1987, 18 days after receiving the submission on October 15, 1987.

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

Submission Details

510(k) Number	K874234 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 1987
Decision Date	November 02, 1987
Days to Decision	18 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—