FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
K Number: K060390
·
Decision Apr 27, 2006
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
250
Applicant Total
21
Review Days
72
Basic Information
- Device Name
- SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
- K Number
- K060390
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GALIL MEDICAL LTD.
- Date Received
- February 14, 2006
- Decision Date
- April 27, 2006
- 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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