The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Grafton Plus Dbm Paste.
| Device ID | K042707 |
| 510k Number | K042707 |
| Device Name: | GRAFTON PLUS DBM PASTE |
| Classification | Bone Grafting Material, Human Source |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2005-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169965102 | K042707 | 000 |
| 00643169123021 | K042707 | 000 |