Avita Nasal Aspirator, Model, NS1 Series

FDA 510(k) K090379 · Avita Corporation

Substantially Equivalent

510(k) numberK090379

Submission

Device name
Avita Nasal Aspirator, Model, NS1 Series
Applicant
Avita Corporation
Flagstaff, AZ, US
Received
February 17, 2009
Decision date
May 26, 2010
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 Avita Nasal Aspirator, Model, NS1 Series cleared by the FDA?

Avita Nasal Aspirator, Model, NS1 Series (K090379) received a 510(k) decision of Substantially Equivalent on May 26, 2010, 463 days after the submission was received.

What is the product code of K090379?

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