FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNIVERSAL SUTURE PASSER
K Number: K812566
·
Decision Nov 10, 1981
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
4
Applicant Total
4
Review Days
62
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Basic Information
- Device Name
- UNIVERSAL SUTURE PASSER
- K Number
- K812566
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ortho Pared Instruments, Inc.
- Date Received
- September 9, 1981
- Decision Date
- November 10, 1981
- Product Code
- GDL
- 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 |
|---|---|---|---|
| GDL | Needle, Suturing, Reusable | FDA class 1 | General, Plastic Surgery |
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