The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for 37-702 And 37-703 Pc Rainbow.
Device ID | K900932 |
510k Number | K900932 |
Device Name: | 37-702 AND 37-703 PC RAINBOW |
Classification | Collimator, Orthovoltage, Therapeutic X-ray |
Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
Contact | Glasser |
Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
Product Code | IYI |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-28 |
Decision Date | 1990-12-05 |