DeNovo ID | DEN150028 |
Device Name: | PneumoLiner |
Classification | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
Applicant | ADVANCED SURGICAL CONCEPTS LTD. unit 4 Sunnybank Center, Upper Dargle Road Bray, IE Irl |
Contact | Edward Hyland |
Product Code | PMU |
CFR Regulation Number | 884.4050 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Obstetrics/Gynecology |
Classification Advisory | Obstetrics/Gynecology |
Type | Direct |
Date Received | 2015-06-19 |
Decision Date | 2016-04-07 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |