FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOLD AWAY HUT
K Number: K851858
·
Decision May 14, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
269
Applicant Total
7
Review Days
18
Basic Information
- Device Name
- FOLD AWAY HUT
- K Number
- K851858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- TANNHUT
- Date Received
- April 26, 1985
- Decision Date
- May 14, 1985
- 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 TANNHUT
| K Number | Device Name | ||
|---|---|---|---|
| K851859 | FACIAL/UPPER BODY UNIT | May 14, 1985 | Substantially Equivalent |
| K851255 | SUN BEDS | Apr 18, 1985 | Substantially Equivalent |
| K840137 | SILGMANN SOLARIUM S-TYPE 1218 COMBO | Apr 23, 1984 | Substantially Equivalent |
| K837283 | UNKNOWN | Apr 15, 1983 | Substantially Equivalent |
| K812579 | SUNTANNING HOME UNIT | Oct 8, 1981 | Substantially Equivalent |
| K802756 | SEMI-OVAL MODULAR SUNTANNING BOOTH | Jan 22, 1981 | Substantially Equivalent |