DISPOSABLE ISOLATION GOWN— 510(k) K921058
Substantially EquivalentNat'L Surtex Corp.
FDA 510(k) clearance K921058 for DISPOSABLE ISOLATION GOWN, Substantially Equivalent on 1992-08-11. Applicant: Nat'L Surtex Corp.. Device class: 2.
Clearance details
- Applicant
- Nat'L Surtex 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
- Paterson, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.