IMPERVIOUS ISOLATION GOWN— 510(k) K972410
Substantially EquivalentKentron Health Care, Inc.
FDA 510(k) clearance K972410 for IMPERVIOUS ISOLATION GOWN, Substantially Equivalent on 1997-09-19. Applicant: Kentron Health Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Kentron Health Care, 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
- Springfield, TN, US
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