FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL BLADES & SCAPELS (SMPL. W/510K)
K Number: K812516
·
Decision Oct 2, 1981
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- SURGICAL BLADES & SCAPELS (SMPL. W/510K)
- K Number
- K812516
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Needle Industries(Usa), Inc.
- Date Received
- September 2, 1981
- Decision Date
- October 2, 1981
- 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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Other Clearances by Needle Industries(Usa), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K813256 | HYPODERMIC & SUTURE NEEDLES | Mar 25, 1982 | Substantially Equivalent |