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 Number | 878.4780
|
Classification Product Code |
|
Date Received | 09/22/2008 |
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
|
|
|