The following data is part of a premarket notification filed by Umi International with the FDA for Collimator, Model M-38.
| Device ID | K062788 |
| 510k Number | K062788 |
| Device Name: | COLLIMATOR, MODEL M-38 |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | UMI INTERNATIONAL 129 KENSINGTON AVE. Norwood, NJ 07648 |
| Contact | Kwang C Jung |
| Correspondent | Kwang C Jung UMI INTERNATIONAL 129 KENSINGTON AVE. Norwood, NJ 07648 |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-12-28 |