FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
APILUS ELECTROPIL
K Number: K943928
·
Decision Jan 12, 1995
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
42
Applicant Total
1
Review Days
153
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Basic Information
- Device Name
- APILUS ELECTROPIL
- K Number
- K943928
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dectro Intl., Inc.
- Date Received
- August 12, 1994
- Decision Date
- January 12, 1995
- 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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