K022594 is an FDA 510(k) clearance for the PLAYTEX BREAST PUMP, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Playtex Products, Inc. (Allendale, US). The FDA issued a Cleared decision on November 1, 2002, 88 days after receiving the submission on August 5, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K022594 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 2002 |
| Decision Date | November 01, 2002 |
| Days to Decision | 88 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 |