The following data is part of a premarket notification filed by Comet Ltd. C/o Radiology Resources, Inc. with the FDA for Tube Housing Assemblies.
| Device ID | K912338 |
| 510k Number | K912338 |
| Device Name: | TUBE HOUSING ASSEMBLIES |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | COMET LTD. C/O RADIOLOGY RESOURCES, INC. WALDEGGSTRASSE 72 CH-3097 LIEBEFELD-BERNE Switzerland, CH |
| Contact | Frey |
| Correspondent | Frey COMET LTD. C/O RADIOLOGY RESOURCES, INC. WALDEGGSTRASSE 72 CH-3097 LIEBEFELD-BERNE Switzerland, CH |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-08-07 |