The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Harris Cement Restrictor.
| Device ID | K810353 |
| 510k Number | K810353 |
| Device Name: | HARRIS CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| Applicant | CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-10 |
| Decision Date | 1981-02-23 |