The following data is part of a premarket notification filed by Northfleet Management Group, Inc. with the FDA for Mangar Booster.
| Device ID | K905414 |
| 510k Number | K905414 |
| Device Name: | MANGAR BOOSTER |
| Classification | Lift, Patient, Ac-powered |
| Applicant | NORTHFLEET MANAGEMENT GROUP, INC. THE MANOR HOUSE 2 HAYDEN ROWE Hopkinton, MA 01748 |
| Contact | Michael L Barretti |
| Correspondent | Michael L Barretti NORTHFLEET MANAGEMENT GROUP, INC. THE MANOR HOUSE 2 HAYDEN ROWE Hopkinton, MA 01748 |
| Product Code | FNG |
| CFR Regulation Number | 880.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-03 |
| Decision Date | 1991-03-05 |