The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Gbr System.
| Device ID | K011698 |
| 510k Number | K011698 |
| Device Name: | STRAUMANN GBR SYSTEM |
| Classification | Plate, Bone |
| Applicant | INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-01 |
| Decision Date | 2001-08-23 |
| Summary: | summary |