FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNIVERSALL DRILL GUIDE
K Number: K820226
·
Decision Feb 4, 1982
Classifications
1
FEI Numbers
560
Registration Numbers
560
Same Product Code
10
Applicant Total
4
Review Days
8
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Basic Information
- Device Name
- UNIVERSALL DRILL GUIDE
- K Number
- K820226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Ortho Pared Instruments, Inc.
- Date Received
- January 27, 1982
- Decision Date
- February 4, 1982
- Product Code
- HTW
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HTW | Bit, Drill | FDA class 1 | Orthopedic |
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