The following data is part of a premarket notification filed by Comet North America, Inc. with the FDA for Mcs 50mo X-ray Tube Insert/mxs 50mo Tube Hou Assem.
| Device ID | K913301 |
| 510k Number | K913301 |
| Device Name: | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | COMET NORTH AMERICA, INC. 4 BYINGTON PLACE Norwalk, CT 06850 |
| Contact | Suffredini |
| Correspondent | Suffredini COMET NORTH AMERICA, INC. 4 BYINGTON PLACE Norwalk, CT 06850 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1991-08-28 |