The following data is part of a premarket notification filed by Cardinal Health 200, Inc. with the FDA for Smartgowntm Surgical Gown.
| Device ID | K150151 |
| 510k Number | K150151 |
| Device Name: | SmartGownTM Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | CARDINAL HEALTH 200, INC. 1500 WAUKEGAN ROAD Waukegan, IL 60685 |
| Contact | Lavenia Ford |
| Correspondent | Lavenia Ford CARDINAL HEALTH 200, INC. 1500 WAUKEGAN ROAD Waukegan, IL 60685 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-23 |
| Decision Date | 2015-05-21 |
| Summary: | summary |