The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Cement Restrictor System.
| Device ID | K943378 |
| 510k Number | K943378 |
| Device Name: | IMPLEX CEMENT RESTRICTOR SYSTEM |
| Classification | Cement Obturator |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | David W Schlert |
| Correspondent | David W Schlert IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-09-23 |