The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Cement Restrictor For Proforma And Perfecta Total.
| Device ID | K923909 |
| 510k Number | K923909 |
| Device Name: | CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL |
| Classification | Cement Obturator |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | David A Cannistraci |
| Correspondent | David A Cannistraci ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1992-11-04 |