FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EPITRON SUPER
K Number: K834572
·
Decision Apr 23, 1984
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
42
Applicant Total
3
Review Days
116
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Basic Information
- Device Name
- EPITRON SUPER
- K Number
- K834572
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Leo Unlimited, Inc.
- Date Received
- December 29, 1983
- Decision Date
- April 23, 1984
- Product Code
- KCW
- 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 |
|---|---|---|---|
| KCW | Epilator, High Frequency, Needle-Type | FDA class 1 | General, Plastic Surgery |
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