FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXIE THE COPPER SHANK NEEDLE
K Number: K874891
·
Decision Jan 7, 1988
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
42
Applicant Total
2
Review Days
37
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Basic Information
- Device Name
- FLEXIE THE COPPER SHANK NEEDLE
- K Number
- K874891
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Skin Deep, Inc.
- Date Received
- December 1, 1987
- Decision Date
- January 7, 1988
- 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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Other Clearances by Skin Deep, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911983 | WIZARD STERILIZED ELECTROEPILATION NEEDLE | Oct 15, 1991 | Substantially Equivalent |