The following data is part of a premarket notification filed by Philips Electronics Uk Limited with the FDA for Handheld Manual Breast Pump (avent Manual Breast Pump).
| Device ID | K101538 |
| 510k Number | K101538 |
| Device Name: | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) |
| Classification | Pump, Breast, Non-powered |
| Applicant | PHILIPS ELECTRONICS UK LIMITED PAMPISFORD ROAD Great Abington, Cambridge, GB Cb21 6ah |
| Contact | Diana Korda Hewitt |
| Correspondent | Diana Korda Hewitt PHILIPS ELECTRONICS UK LIMITED PAMPISFORD ROAD Great Abington, Cambridge, GB Cb21 6ah |
| Product Code | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2010-11-05 |
| Summary: | summary |