K875300 is an FDA 510(k) clearance for the MEDELA BREAST-PUMP LACTINA. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Medela, Inc. (Chicago, US). The FDA issued a Cleared decision on April 6, 1988, 99 days after receiving the submission on December 29, 1987.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K875300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1987 |
| Decision Date | April 06, 1988 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |