CARETEX ISOLUTION GOWNS— 510(k) K864479
Substantially EquivalentJames River Corp.
FDA 510(k) clearance K864479 for CARETEX ISOLUTION GOWNS, Substantially Equivalent on 1986-12-09. Applicant: James River Corp.. Device class: 2.
Clearance details
- Applicant
- James River Corp.
- 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
- Neenah, WI, US
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