The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Extraoral Implant System.
| Device ID | K990458 |
| 510k Number | K990458 |
| Device Name: | STRAUMANN EXTRAORAL IMPLANT SYSTEM |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | STRAUMANN USA RESERVOIR PLACE, 1601 TRAPELO ROAD Waltham, MA 02154 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert STRAUMANN USA RESERVOIR PLACE, 1601 TRAPELO ROAD Waltham, MA 02154 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-12 |
| Decision Date | 1999-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031722409 | K990458 | 000 |