The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela Pump In Style Advanced Breast Pump.
| Device ID | K031614 |
| 510k Number | K031614 |
| Device Name: | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA, INC. 1101 CORPORATE DR. Mchenry, IL 60050 -7005 |
| Contact | Christopher L Peterson |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-05-23 |
| Decision Date | 2003-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20020451382993 | K031614 | 000 |
| 00020451570365 | K031614 | 000 |
| 00020451570815 | K031614 | 000 |
| 10020451570638 | K031614 | 000 |
| 20020451570628 | K031614 | 000 |
| 10020451570454 | K031614 | 000 |
| 20020451570185 | K031614 | 000 |
| 10020451350780 | K031614 | 000 |
| 10020451350773 | K031614 | 000 |