The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for The Lifecore Stage-1 Angled Abutment System.
| Device ID | K032495 |
| 510k Number | K032495 |
| Device Name: | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Diane Brinza |
| Correspondent | Diane Brinza LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-13 |
| Decision Date | 2003-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D76842002K0 | K032495 | 000 |
| D76842001K | K032495 | 000 |
| D76842000K0 | K032495 | 000 |