The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Tiburon Drape, Model 9349n/ Optima Drape, Model 9446n.
| Device ID | K061762 |
| 510k Number | K061762 |
| Device Name: | TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N |
| Classification | Drape, Surgical |
| Applicant | CARDINAL HEALTH, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Lavenia Ford CARDINAL HEALTH, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-22 |
| Decision Date | 2006-08-01 |
| Summary: | summary |