The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Healthtm Poly-coated Open-back Protective Gown.
| Device ID | K182830 |
| 510k Number | K182830 |
| Device Name: | Cardinal HealthTM Poly-Coated Open-Back Protective Gown |
| Classification | Gown, Isolation, 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 | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-05 |
| Decision Date | 2019-04-26 |