K962828 is an FDA 510(k) clearance for the EVERT-IT. This device is classified as a Pump, Breast, Non-powered (Class I - General Controls, product code HGY).
Submitted by Genesis Industries, Inc. (Elmwood, US). The FDA issued a Cleared decision on February 10, 1997, 206 days after receiving the submission on July 19, 1996.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5150.
| 510(k) Number | K962828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1996 |
| Decision Date | February 10, 1997 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGY — Pump, Breast, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.5150 |