FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GELZONE
K Number: K013732
·
Decision Feb 7, 2002
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
41
Review Days
90
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Basic Information
- Device Name
- GELZONE
- K Number
- K013732
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implantech Associates, Inc.
- Date Received
- November 9, 2001
- Decision Date
- February 7, 2002
- 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 |
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