FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HANDISOL WOUND HEALING
K Number: K982082
·
Decision Oct 28, 1998
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
27
Review Days
135
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Basic Information
- Device Name
- HANDISOL WOUND HEALING
- K Number
- K982082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- National Biological Corp.
- Date Received
- June 15, 1998
- Decision Date
- October 28, 1998
- Product Code
- FTC
- 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | FDA class 2 | General, Plastic Surgery |
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Other Clearances by National Biological Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K070934 | PANOSOL II TRU-BLU, MODEL UBL-417 | May 22, 2007 | Substantially Equivalent |
| K041212 | HOUVA 3 PHOTOTHERAPY SYSTEM | Jun 9, 2004 | Substantially Equivalent |
| K934808 | UVISOL AND UVISOL II | Dec 16, 1993 | Substantially Equivalent |
| K924969 | PHOTOTHERAPY TIMER | Feb 23, 1993 | Substantially Equivalent |
| K924077 | HANDISOL | Nov 20, 1992 | Substantially Equivalent |
| K904427 | PANOSOL II UVB-206 | Dec 24, 1990 | Substantially Equivalent |
| K904426 | PANOSOL II UVA-218 | Dec 24, 1990 | Substantially Equivalent |
| K904428 | PANOSOL II UAB-228 | Dec 24, 1990 | Substantially Equivalent |
| K885029 | HOUVA II UVA/UVB | Jun 2, 1989 | Substantially Equivalent |
| K885026 | HOUVA II UVB | Jun 2, 1989 | Substantially Equivalent |