BARRIER GOWN, KOOL-GARD BACKLESS GOWN— 510(k) K952115
Substantially EquivalentAmerican Threshold Industries, Inc.
FDA 510(k) clearance K952115 for BARRIER GOWN, KOOL-GARD BACKLESS GOWN, Substantially Equivalent on 1995-09-25. Applicant: American Threshold Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- American Threshold Industries, 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
- Enka, NC, US
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