The following data is part of a premarket notification filed by Regen Biologics, Inc. with the FDA for Regen Collagen Scaffold (cs).
| Device ID | K082079 |
| 510k Number | K082079 |
| Device Name: | REGEN COLLAGEN SCAFFOLD (CS) |
| Classification | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen |
| Applicant | REGEN BIOLOGICS, INC. 411 HACKENSACK AVENUE Hackensack, NJ 07601 |
| Contact | John Dichiara |
| Correspondent | John Dichiara REGEN BIOLOGICS, INC. 411 HACKENSACK AVENUE Hackensack, NJ 07601 |
| Product Code | OLC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2008-12-18 |
| Summary: | summary |