The following data is part of a premarket notification filed by Neucoll, Inc. with the FDA for Collagraft Strip Bone Graft Matrix (for Use As A Bone Filler), Model 1x,3x,6x (1,3 Or 6 Strips Per Box).
| Device ID | K000122 |
| 510k Number | K000122 |
| Device Name: | COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NEUCOLL, INC. 25OO FABER PL. Palo Alto, CA 94303 -3329 |
| Contact | Anne Worden |
| Correspondent | Anne Worden NEUCOLL, INC. 25OO FABER PL. Palo Alto, CA 94303 -3329 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2001-09-20 |