FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE SURGICAL BLADES
K Number: K852141
·
Decision Jun 13, 1985
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- STERILE SURGICAL BLADES
- K Number
- K852141
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Miltex Instrument Co.
- Date Received
- May 16, 1985
- Decision Date
- June 13, 1985
- Product Code
- GES
- 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 |
|---|---|---|---|
| GES | Blade, Scalpel | FDA class 1 | General, Plastic Surgery |
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