Cleared Traditional

EASYGO ASPIRATOR

K971749 · Precision Medical, Inc. · General & Plastic Surgery
Apr 1998
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K971749 is an FDA 510(k) clearance for the EASYGO ASPIRATOR, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on April 1, 1998, 324 days after receiving the submission on May 12, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K971749 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1997
Decision Date April 01, 1998
Days to Decision 324 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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