Cleared Traditional

K884512 - BEAVER(R) HANDLE
(FDA 510(k) Clearance)

K884512 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery

Nov 1988

Decision

21d

Days

Class 1

Risk

K884512 is an FDA 510(k) clearance for the BEAVER(R) HANDLE. This device is classified as a Handle, Scalpel (Class I — General Controls, product code GDZ).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on November 17, 1988, 21 days after receiving the submission on October 27, 1988.

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

Submission Details

510(k) Number	K884512 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 1988
Decision Date	November 17, 1988
Days to Decision	21 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—