The following data is part of a premarket notification filed by Wildcat Ppe, Llc with the FDA for Wildcat Pe Surgical Isolation Gown Open Back, Wildcat Pe Surgical Isolation Gown Full Back.
| Device ID | K202310 |
| 510k Number | K202310 |
| Device Name: | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back |
| Classification | Gown, Isolation, Surgical |
| Applicant | Wildcat PPE, LLC 301 S. Trade Center Pkwy Conroe, TX 77385 |
| Contact | Matthew Mcfarlane |
| Correspondent | Matthew Mcfarlane Wildcat PPE, LLC 301 S. Trade Center Pkwy Conroe, TX 77385 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-14 |
| Decision Date | 2021-01-29 |