FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ICESENCE 3
K Number: K102360
·
Decision Nov 29, 2010
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
4
Review Days
102
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Basic Information
- Device Name
- ICESENCE 3
- K Number
- K102360
- 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
- IceCure Medical , Ltd.
- Date Received
- August 19, 2010
- Decision Date
- November 29, 2010
- 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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