Cleared Traditional

INAMED CONVERTIBLE DRAIN SYSTEM

K901764 · Inamed Development Co. · General & Plastic Surgery
May 1990
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K901764 is an FDA 510(k) clearance for the INAMED CONVERTIBLE 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 May 7, 1990, 19 days after receiving the submission on April 18, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.

Submission Details

510(k) Number K901764 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1990
Decision Date May 07, 1990
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4680

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