The following data is part of a premarket notification filed by Cadillac Products, Inc. with the FDA for Protec-usa Ezdoff Gown.
| Device ID | K210405 |
| 510k Number | K210405 |
| Device Name: | ProTEC-USA EZDoff Gown |
| Classification | Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection |
| Applicant | Cadillac Products, Inc. 5800 Crooks Road, Suite 100 Troy, MI 48098 |
| Contact | Andrew Stone |
| Correspondent | Dennis Gucciardo Morgan Lewis & Bockius LLP 1111 Pennsylvania Ave Washington, DC 20004 -2541 |
| Product Code | QPC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-10 |
| Decision Date | 2021-12-15 |