The following data is part of a premarket notification filed by Tomy International with the FDA for Memory Pump Model Y4947.
| Device ID | K131027 |
| 510k Number | K131027 |
| Device Name: | MEMORY PUMP MODEL Y4947 |
| Classification | Pump, Breast, Powered |
| Applicant | TOMY INTERNATIONAL 45 SHAWMUT ROAD Canton, MA 02021 |
| Contact | Brian Thomas |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-05-30 |