The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health Smartgown Breathable Surgical Gown, Cardinal Health Smartgown Air Breathable Surgical Gown.
| Device ID | K200824 |
| 510k Number | K200824 |
| Device Name: | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown |
| 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 | 2020-03-30 |
| Decision Date | 2020-07-29 |