The following data is part of a premarket notification filed by Bacterin International Inc. with the FDA for Elutia Coated Closed Surgical Wound Drain.
| Device ID | K063245 |
| 510k Number | K063245 |
| Device Name: | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN |
| Classification | Drainage Catheter With Antibiotic |
| Applicant | BACTERIN INTERNATIONAL INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary BACTERIN INTERNATIONAL INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | OEI |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-10-26 |
| Decision Date | 2007-11-28 |
| Summary: | summary |