The following data is part of a premarket notification filed by The First Years, Inc. with the FDA for Natural Comfort Double Electric/battery Breast Pump, Model 1181/1068.
Device ID | K033131 |
510k Number | K033131 |
Device Name: | NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 |
Classification | Pump, Breast, Powered |
Applicant | THE FIRST YEARS, INC. ONE KIDDIE DR. Avon, MA 02322 |
Contact | Robin C Conner |
Correspondent | Robin C Conner 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 | 2003-09-30 |
Decision Date | 2003-10-30 |