FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K Number: K012497
·
Decision Oct 30, 2001
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
23
Review Days
88
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Basic Information
- Device Name
- CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
- K Number
- K012497
- 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
- Galil Medical , Ltd.
- Date Received
- August 3, 2001
- Decision Date
- October 30, 2001
- 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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