510(k) K090379

AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES by Avita Corporation — Product Code BTA

K090379 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES". The FDA issued a decision of Substantially Equivalent on May 26, 2010. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Avita Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2010
Date Received
Feb 17, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type