K011519 is an FDA 510(k) clearance for the AMEDA HYGIENIKIT. This device is classified as a Pump, Breast, Non-powered (Class I - General Controls, product code HGY).
Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on August 15, 2001, 90 days after receiving the submission on May 17, 2001.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5150.
| 510(k) Number | K011519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2001 |
| Decision Date | August 15, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGY — Pump, Breast, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.5150 |