Cleared Traditional

K896491 - INAMED CLOSED-WOUND DRAIN SYSTEM
(FDA 510(k) Clearance)

K896491 · Inamed Development Co. · General & Plastic Surgery

Jan 1990

Decision

56d

Days

Class 1

Risk

K896491 is an FDA 510(k) clearance for the INAMED CLOSED-WOUND DRAIN SYSTEM, a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I — General Controls, product code GCY), submitted by Inamed Development Co. (Carpinteria, US). The FDA issued a Cleared decision on January 8, 1990, 56 days after receiving the submission on November 13, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.

Submission Details

510(k) Number	K896491 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1989
Decision Date	January 08, 1990
Days to Decision	56 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—