Supraflow Console

FDA 510(k) K040239 · Neomedix Corp.

Substantially Equivalent

510(k) numberK040239

Submission

Device name
Supraflow Console
Applicant
Neomedix Corp.
San Juan Capistrano, CA, US
Received
February 2, 2004
Decision date
February 17, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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Questions and answers

When was Supraflow Console cleared by the FDA?

Supraflow Console (K040239) received a 510(k) decision of Substantially Equivalent on February 17, 2004, 15 days after the submission was received.

What is the product code of K040239?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.