FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AHRS EPILATOR 629
K Number: K892514
·
Decision Aug 14, 1990
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
24
Applicant Total
1
Review Days
490
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Basic Information
- Device Name
- AHRS EPILATOR 629
- K Number
- K892514
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5360
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Hair Removal System Co.
- Date Received
- April 11, 1989
- Decision Date
- August 14, 1990
- 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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