The following data is part of a premarket notification filed by The Straumann Co. with the FDA for Straumann Granules.
| Device ID | K040646 |
| 510k Number | K040646 |
| Device Name: | STRAUMANN GRANULES |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | THE STRAUMANN CO. RESERVOIR PL. 1601 TRAPELO RD. Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert THE STRAUMANN CO. RESERVOIR PL. 1601 TRAPELO RD. Waltham, MA 02451 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-11 |
| Decision Date | 2004-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031700179 | K040646 | 000 |
| 07630031700162 | K040646 | 000 |
| 07630031700155 | K040646 | 000 |