The following data is part of a premarket notification filed by L. Keroack Co. with the FDA for Densicomp 250.
| Device ID | K904587 |
| 510k Number | K904587 |
| Device Name: | DENSICOMP 250 |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | L. KEROACK CO. 4841 WILSON ST. MONTREAL, QC, CANADA H3X 3P3, CA |
| Contact | LUCIEN KEROACK |
| Correspondent | LUCIEN KEROACK L. KEROACK CO. 4841 WILSON ST. MONTREAL, QC, CANADA H3X 3P3, CA |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-09 |
| Decision Date | 1991-01-24 |