Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back— 510(k) K202310
Substantially EquivalentWildcat Ppe, LLC
FDA 510(k) clearance K202310 for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back, Substantially Equivalent on 2021-01-29. Applicant: Wildcat Ppe, LLC. Device class: 2.
Clearance details
- Applicant
- Wildcat Ppe, LLC
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Conroe, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.