The following data is part of a premarket notification filed by The First Years, Inc. with the FDA for Easy Comfort Deluxe Manual Breast Pump, Model 1187.
| Device ID | K032845 |
| 510k Number | K032845 |
| Device Name: | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 |
| Classification | Pump, Breast, Non-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 | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-11 |
| Decision Date | 2004-04-05 |