The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Veridose V (five), Model Number 37-705.
Device ID | K964952 |
510k Number | K964952 |
Device Name: | VERIDOSE V (FIVE), MODEL NUMBER 37-705 |
Classification | System, Therapeutic, X-ray |
Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
Contact | Linda S Morin |
Correspondent | Linda S Morin VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
Product Code | JAD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-10 |
Decision Date | 1997-07-21 |
Summary: | summary |