The following data is part of a premarket notification filed by Sulzer Calcitek, Inc. with the FDA for Removable Cuff Abutment.
| Device ID | K984536 |
| 510k Number | K984536 |
| Device Name: | REMOVABLE CUFF ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Foster Boop |
| Correspondent | Foster Boop SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-06-16 |
| Summary: | summary |