Cleared Traditional

K974038 - THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT
(FDA 510(k) Clearance)

K974038 · A & A Medical, Inc. · General & Plastic Surgery
May 1998
Decision
199d
Days
Class 2
Risk

K974038 is an FDA 510(k) clearance for the THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on May 11, 1998, 199 days after receiving the submission on October 24, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K974038 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1997
Decision Date May 11, 1998
Days to Decision 199 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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