FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Hydrozid
K Number: K201740
·
Decision Jul 7, 2021
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
1
Review Days
377
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Basic Information
- Device Name
- Hydrozid
- K Number
- K201740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medilink A/S
- Date Received
- June 25, 2020
- Decision Date
- July 7, 2021
- Product Code
- GEH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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