FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
SIL-K
K Number: K914701
·
Decision Jan 31, 1992
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
19
Review Days
105
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Basic Information
- Device Name
- SIL-K
- K Number
- K914701
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Degania Silicone , Ltd.
- Date Received
- October 18, 1991
- Decision Date
- January 31, 1992
- Product Code
- MDA
- 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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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FDA 510(k)
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