FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIMISIL SCAR GEL
K Number: K023678
·
Decision Jan 23, 2003
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
10
Review Days
83
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Basic Information
- Device Name
- DIMISIL SCAR GEL
- K Number
- K023678
- 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
- Aesthetic and Reconstructive Technologies, Inc.
- Date Received
- November 1, 2002
- Decision Date
- January 23, 2003
- 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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Other Clearances by Aesthetic and Reconstructive Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022306 | AART SILICONE TUBING | Oct 10, 2002 | Substantially Equivalent |
| K022511 | AART CALF IMPLANT | Aug 26, 2002 | Substantially Equivalent |
| K022223 | AART SILICONE SHEETING | Aug 8, 2002 | Substantially Equivalent |
| K021820 | AART SILICONE CARVING BLOCK | Jul 16, 2002 | Substantially Equivalent |
| K021839 | AART GLUTEAL IMPLANT | Jul 16, 2002 | Substantially Equivalent |
| K021337 | AART PECTORALIS IMPLANT | Jul 3, 2002 | Substantially Equivalent |
| K021417 | AART CHIN IMPLANT | Jul 2, 2002 | Substantially Equivalent |
| K021419 | AART MALAR IMPLANT | Jul 2, 2002 | Substantially Equivalent |
| K021418 | AART NASAL IMPLANT | Jul 2, 2002 | Substantially Equivalent |