Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S

FDA 510(k) K061133 · Novaspine, LLC

Substantially Equivalent

510(k) numberK061133

Submission

Device name
Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S
Applicant
Novaspine, LLC
Elmsford, NY, US
Received
April 24, 2006
Decision date
July 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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 Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S cleared by the FDA?

Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S (K061133) received a 510(k) decision of Substantially Equivalent on July 11, 2006, 78 days after the submission was received.

What is the product code of K061133?

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