The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Metal-backed Acetabular Cup.
| Device ID | K831479 |
| 510k Number | K831479 |
| Device Name: | METAL-BACKED ACETABULAR CUP |
| Classification | Blood Pressure Cuff |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-09 |
| Decision Date | 1983-06-15 |