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 |