The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health Isolation Gown.
| Device ID | K160339 |
| 510k Number | K160339 |
| Device Name: | Cardinal Health Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085 |
| Contact | Caroline Miceli |
| Correspondent | Caroline Miceli Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-07-28 |
| Summary: | summary |