FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEPILATOR, DERMA-I & DERMA-II
K Number: K770791
·
Decision Jan 26, 1981
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
24
Applicant Total
1
Review Days
1365
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Basic Information
- Device Name
- DEPILATOR, DERMA-I & DERMA-II
- K Number
- K770791
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5360
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Electro-Kinetic Eng/Mfg
- Date Received
- May 2, 1977
- Decision Date
- January 26, 1981
- Product Code
- KCX
- 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 |
|---|---|---|---|
| KCX | Epilator, High Frequency, Tweezer-Type | FDA class 1 | General, Plastic Surgery |
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