FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPID FIRE HAIR IMPLANTER CAROUSEL
K Number: K972918
·
Decision Oct 27, 1997
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
6
Applicant Total
1
Review Days
81
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Basic Information
- Device Name
- RAPID FIRE HAIR IMPLANTER CAROUSEL
- K Number
- K972918
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex Medical Products, LLC
- Date Received
- August 7, 1997
- Decision Date
- October 27, 1997
- Product Code
- GAH
- 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 |
|---|---|---|---|
| GAH | Stylet, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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