FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KEISEI SCALPEL (STERILE AND NON-STERILE)
K Number: K863213
·
Decision Sep 2, 1986
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
25
Applicant Total
4
Review Days
13
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Basic Information
- Device Name
- KEISEI SCALPEL (STERILE AND NON-STERILE)
- K Number
- K863213
- 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
- GDX
- 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 |
|---|---|---|---|
| GDX | Scalpel, One-Piece | FDA class 1 | General, Plastic Surgery |
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