The following data is part of a premarket notification filed by The First Years, Inc. with the FDA for Natural Comfort Battery/electric Breast Pump.
Device ID | K032566 |
510k Number | K032566 |
Device Name: | NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP |
Classification | Pump, Breast, Powered |
Applicant | THE FIRST YEARS, INC. ONE KIDDIE DR. Avon, MA 02322 |
Contact | Robin C Connor |
Correspondent | Robin C Connor THE FIRST YEARS, INC. ONE KIDDIE DR. Avon, MA 02322 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-21 |
Decision Date | 2003-09-15 |