Rami Tan Ultraviolet B Booth
FDA 510(k) K801752 · Rami-Tan
510(k) numberK801752
Submission
- Device name
- Rami Tan Ultraviolet B Booth
- Applicant
- Rami-Tan
Mchenry, IL, US - Received
- July 28, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LEJ – Booth, Sun Tan
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4635
- Specialty
- General, Plastic Surgery
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More from Lpi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801751 | Rami Ultraviolet a BoothLEJ · Traditional | 09/16/1980SE |
Questions and answers
When was Rami Tan Ultraviolet B Booth cleared by the FDA?
Rami Tan Ultraviolet B Booth (K801752) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 50 days after the submission was received.
What is the product code of K801752?
The FDA product code is LEJ – Booth, Sun Tan, a Class II (moderate risk) device regulated under 21 CFR 878.4635.