The following data is part of a premarket notification filed by Hersill, S.l. with the FDA for V7 Portable Suction Units.
| Device ID | K093241 |
| 510k Number | K093241 |
| Device Name: | V7 PORTABLE SUCTION UNITS |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | HERSILL, S.L. PUERTO DE NAVACERRADA, 3 Mostoles ( Madrid), ES 28935 |
| Contact | Oscar Jordan |
| Correspondent | Jeff Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-15 |
| Decision Date | 2010-04-27 |