FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTRUM DESIGNS SPECTRAGEL
K Number: K992522
·
Decision Oct 26, 1999
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
18
Review Days
90
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Basic Information
- Device Name
- SPECTRUM DESIGNS SPECTRAGEL
- K Number
- K992522
- 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
- Spectrum Designs, Inc.
- Date Received
- July 28, 1999
- Decision Date
- October 26, 1999
- 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
Other 510(k) clearances with the same product code (MDA), ordered by most recent decision date.
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HANSON SCAR ADE
FDA 510(k)
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Other Clearances by Spectrum Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | Oct 13, 1998 | Substantially Equivalent |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | Apr 3, 1998 | Substantially Equivalent |
| K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | Mar 4, 1998 | Substantially Equivalent |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | Mar 3, 1998 | Substantially Equivalent |
| K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | Mar 3, 1998 | Substantially Equivalent |