FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILGMANN SOLARIUM SUN-MOBIL MODEL 0918
K Number: K860856
·
Decision Mar 28, 1986
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
269
Applicant Total
1
Review Days
21
Basic Information
- Device Name
- SILGMANN SOLARIUM SUN-MOBIL MODEL 0918
- K Number
- K860856
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- SOLARIUM TANNING HUT
- Date Received
- March 7, 1986
- Decision Date
- March 28, 1986
- 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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