FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
K Number: K895409
·
Decision Oct 20, 1989
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
80
Applicant Total
3
Review Days
44
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Basic Information
- Device Name
- REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
- K Number
- K895409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4635
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Remington Products Company, LLC
- Date Received
- September 6, 1989
- Decision Date
- October 20, 1989
- Product Code
- LEJ
- 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 |
|---|---|---|---|
| LEJ | Booth, Sun Tan | FDA class 2 | General, Plastic Surgery |
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