Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K161725 |
Device Name |
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail |
Applicant |
MEDELA, INC |
1101 CORPORATE DRIVE |
MCHENRY,
IL
60050
|
|
Applicant Contact |
ROBERT SOKOLOWSKI |
Correspondent |
PATHWAY REGULATORY CONSULTING, LLC |
W324S3649 COUNTY ROAD E |
DOUSMAN,
WI
53118
|
|
Correspondent Contact |
ADRIENNE LENZ |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 06/22/2016 |
Decision Date | 10/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|