The following data is part of a premarket notification filed by Cmsi with the FDA for Collimator, Bilaterial.
Device ID | K790168 |
510k Number | K790168 |
Device Name: | COLLIMATOR, BILATERIAL |
Classification | Device, Beam Limiting, X-ray, Therapeutic |
Applicant | CMSI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQA |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-23 |
Decision Date | 1979-02-15 |