COATED ISOLATION GOWN— 510(k) K891677
Substantially EquivalentDurante Intl., Inc.
FDA 510(k) clearance K891677 for COATED ISOLATION GOWN, Substantially Equivalent on 1989-04-20. Applicant: Durante Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Durante Intl., Inc.
- 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
- Houston, TX, US
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