The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Biobuck Cement Restrictor.
| Device ID | K023680 |
| 510k Number | K023680 |
| Device Name: | BIOBUCK CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2002-11-19 |
| Summary: | summary |