The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health Chemoplus Full Coverage Gown, Closed Back, Cardinal Health Chemoplus Full Coverage Gown, Open Back, Cardinal Health Chemoplus Full Coverage Sleeve.
| Device ID | K193327 |
| 510k Number | K193327 |
| Device Name: | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve |
| Classification | Gown, Surgical |
| Applicant | Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 |
| Contact | Caroline Miceli |
| Correspondent | Caroline Miceli Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-03-20 |