FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL BUR
K Number: K943758
·
Decision Aug 22, 1994
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
15
Applicant Total
3
Review Days
20
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Basic Information
- Device Name
- SURGICAL BUR
- K Number
- K943758
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Komet Medical
- Date Received
- August 2, 1994
- Decision Date
- August 22, 1994
- Product Code
- GFF
- 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 |
|---|---|---|---|
| GFF | Bur, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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