FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KEISEI HANDLES FOR SURGICAL BLADES
K Number: K863212
·
Decision Sep 2, 1986
Classifications
1
FEI Numbers
443
Registration Numbers
443
Same Product Code
15
Applicant Total
4
Review Days
13
Basic Information
- Device Name
- KEISEI HANDLES FOR SURGICAL BLADES
- K Number
- K863212
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- KEISEI MEDICAL INDUSTRIAL CO., LTD.
- Date Received
- August 20, 1986
- Decision Date
- September 2, 1986
- Product Code
- GDZ
- 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 |
|---|---|---|---|
| GDZ | Handle, Scalpel | FDA class 1 | General, Plastic Surgery |
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