K101538 is an FDA 510(k) clearance for the HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP). This device is classified as a Pump, Breast, Non-powered (Class I - General Controls, product code HGY).
Submitted by Philips Electronics UK Limited (Great Abington, Cambridge, GB). The FDA issued a Cleared decision on November 5, 2010, 155 days after receiving the submission on June 3, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5150.
| 510(k) Number | K101538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2010 |
| Decision Date | November 05, 2010 |
| Days to Decision | 155 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 |