The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Cemstop Cement Restrictor.
| Device ID | K032685 |
| 510k Number | K032685 |
| Device Name: | CEMSTOP CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| Applicant | TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-29 |
| Decision Date | 2003-11-26 |
| Summary: | summary |