The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Tiburon Surgical Drape.
| Device ID | K130404 |
| 510k Number | K130404 |
| Device Name: | TIBURON SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | CARDINAL HEALTH 200, LLC 1430 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Lavenia Ford CARDINAL HEALTH 200, LLC 1430 WAUKEGAN ROAD Waukegan, IL 60085 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-07-05 |
| Summary: | summary |