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 |