Freedom Aspirator, Model 6000

FDA 510(k) K944116 · Stackhouse, Inc.

Substantially Equivalent

510(k) numberK944116

Submission

Device name
Freedom Aspirator, Model 6000
Applicant
Stackhouse, Inc.
Riverside, CA, US
Received
August 23, 1994
Decision date
September 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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More from Shenzhen Kingboom Technology Co., Ltd.

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Questions and answers

When was Freedom Aspirator, Model 6000 cleared by the FDA?

Freedom Aspirator, Model 6000 (K944116) received a 510(k) decision of Substantially Equivalent on September 7, 1994, 15 days after the submission was received.

What is the product code of K944116?

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