FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE #11 SCALPEL BLADE W/SHORT
K Number: K820869
·
Decision May 5, 1982
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
25
Applicant Total
52
Review Days
37
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Basic Information
- Device Name
- DISPOSABLE #11 SCALPEL BLADE W/SHORT
- K Number
- K820869
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Van-Tec, Inc.
- Date Received
- March 29, 1982
- Decision Date
- May 5, 1982
- 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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