The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Breast Pump.
| Device ID | K022594 |
| 510k Number | K022594 |
| Device Name: | PLAYTEX BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Paul A Siracusa |
| Correspondent | Paul A Siracusa PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-05 |
| Decision Date | 2002-11-01 |
| Summary: | summary |