FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLAR WAND
K Number: K021387
·
Decision Jul 31, 2002
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- POLAR WAND
- K Number
- K021387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chek-Med Systems
- Date Received
- May 2, 2002
- Decision Date
- July 31, 2002
- 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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