The following data is part of a premarket notification filed by Cardinal Health 200, Inc. with the FDA for Trimax, Model 9515n, Breathable Surgical Gown, Models 3247an And 9015n And Optima Or Surgical Gown, Model 9506n.
| Device ID | K061308 |
| 510k Number | K061308 |
| Device Name: | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N |
| Classification | Gown, Surgical |
| Applicant | CARDINAL HEALTH 200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60685 |
| Contact | Lavenia Ford |
| Correspondent | Lavenia Ford CARDINAL HEALTH 200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60685 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-10 |
| Decision Date | 2006-06-05 |
| Summary: | summary |