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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K090379
FOIA Releasable 510(k) K090379
Device Name AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
Applicant
AVITA CORPORATION
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
AVITA CORPORATION
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number878.4780
Classification Product Code
BTA  
Date Received02/17/2009
Decision Date 05/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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