The following data is part of a premarket notification filed by Advance Medical Device, Inc. with the FDA for Floscope Vascular Lab..
| Device ID | K905157 |
| 510k Number | K905157 |
| Device Name: | FLOSCOPE VASCULAR LAB. |
| Classification | Transducer, Ultrasonic |
| Applicant | ADVANCE MEDICAL DEVICE, INC. 2733 SAUNDERS ST. P.O. BOX 1419 Camden, NJ 08105 |
| Contact | David Lerner |
| Correspondent | David Lerner ADVANCE MEDICAL DEVICE, INC. 2733 SAUNDERS ST. P.O. BOX 1419 Camden, NJ 08105 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-16 |
| Decision Date | 1991-03-15 |