K964403 is an FDA 510(k) clearance for the SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by The First Years, Inc. (Avon, US). The FDA issued a Cleared decision on January 13, 1997, 70 days after receiving the submission on November 4, 1996.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K964403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1996 |
| Decision Date | January 13, 1997 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |