FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EPILATION TYPE DEVICE
K Number: K780348
·
Decision May 18, 1978
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
24
Applicant Total
1
Review Days
77
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Basic Information
- Device Name
- EPILATION TYPE DEVICE
- K Number
- K780348
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5360
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mehl, Thomas L.
- Date Received
- March 2, 1978
- Decision Date
- May 18, 1978
- 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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