The following data is part of a premarket notification filed by Magma Corp. with the FDA for Mg-1001 Tube Housing Assembly.
| Device ID | K921316 |
| 510k Number | K921316 |
| Device Name: | MG-1001 TUBE HOUSING ASSEMBLY |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | MAGMA CORP. P.O. BOX 1263 Teaneck, NJ 07666 |
| Contact | Michael Ringart |
| Correspondent | Michael Ringart MAGMA CORP. P.O. BOX 1263 Teaneck, NJ 07666 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1992-06-22 |