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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, suction, ward use, portable, ac-powered
510(k) Number K082762
Device Name AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
Applicant
AARDVARK MEDICAL
PO BOX 1654
ROSS,  CA  94957
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4780
Classification Product Code
JCX  
Date Received09/22/2008
Decision Date 11/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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