K032845 is an FDA 510(k) clearance for the EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187. This device is classified as a Pump, Breast, Non-powered (Class I - General Controls, product code HGY).
Submitted by The First Years, Inc. (Avon, US). The FDA issued a Cleared decision on April 5, 2004, 207 days after receiving the submission on September 11, 2003.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5150.
| 510(k) Number | K032845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2003 |
| Decision Date | April 05, 2004 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGY — Pump, Breast, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.5150 |