DISARP ORIGINAL— 510(k) K802248
Substantially EquivalentUnoplast A/S
FDA 510(k) clearance K802248 for DISARP ORIGINAL, Substantially Equivalent on 1980-09-26. Applicant: Unoplast A/S. Device class: 2.
Clearance details
- Applicant
- Unoplast A/S
- Product code
- Code GAO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4495
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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