Cleared Traditional

INAMED DEVELOPMENT ASPIRATION TIP

K931548 · Inamed Development Co. · General Hospital
Jan 1994
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K931548 is an FDA 510(k) clearance for the INAMED DEVELOPMENT ASPIRATION TIP, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Inamed Development Co. (Carpinteria, US). The FDA issued a Cleared decision on January 10, 1994, 287 days after receiving the submission on March 29, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K931548 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1993
Decision Date January 10, 1994
Days to Decision 287 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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