510(k) K090379

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2010
Date Received
February 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