The following data is part of a premarket notification filed by Mastek, Inc. with the FDA for Radiolucent Cassette Limb Positioner (r-clip).
| Device ID | K983918 |
| 510k Number | K983918 |
| Device Name: | RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) |
| Classification | Cassette, Radiographic Film |
| Applicant | MASTEK, INC. 1200 BINZ, SUITE 1200 Houston, TX 77004 |
| Contact | Marcos V Masson |
| Correspondent | Marcos V Masson MASTEK, INC. 1200 BINZ, SUITE 1200 Houston, TX 77004 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-04 |
| Decision Date | 1999-03-12 |