The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Link Cement Plug.
| Device ID | K972411 |
| 510k Number | K972411 |
| Device Name: | LINK CEMENT PLUG |
| Classification | Cement Obturator |
| Applicant | TURNKEY INTERGRATION USA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart TURNKEY INTERGRATION USA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-08-29 |