FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOLDER, NEEDLE
K Number: K890167
·
Decision Feb 3, 1989
Classifications
1
FEI Numbers
241
Registration Numbers
241
Same Product Code
4
Applicant Total
14
Review Days
25
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Basic Information
- Device Name
- HOLDER, NEEDLE
- K Number
- K890167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Dhason Brothers, Inc.
- Date Received
- January 9, 1989
- Decision Date
- February 3, 1989
- Product Code
- HXK
- 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 |
|---|---|---|---|
| HXK | Holder, Needle; Orthopedic | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Dhason Brothers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890160 | GOUGES FOR FEMORAL HEADS | Feb 13, 1989 | Substantially Equivalent |
| K890168 | RETRACTOR, SELF-RETAINING | Feb 13, 1989 | Substantially Equivalent |
| K890161 | THOMPSON TYPE RASP W/TOMMY BAR | Feb 13, 1989 | Substantially Equivalent |
| K890166 | RONGUER-ORTHOPEDIC | Feb 13, 1989 | Substantially Equivalent |
| K890156 | IMPACTOR FOR FEMORAL HEAD | Feb 13, 1989 | Substantially Equivalent |
| K890162 | EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD | Feb 13, 1989 | Substantially Equivalent |
| K890163 | AUSTIN MOORE HALLOW CHISEL | Feb 13, 1989 | Substantially Equivalent |
| K890164 | HUDSON BRACE W/BURRS | Feb 13, 1989 | Substantially Equivalent |
| K890158 | RETRACTORS | Feb 13, 1989 | Substantially Equivalent |
| K890165 | FORCEPS-ORTHOPEDIC | Feb 13, 1989 | Substantially Equivalent |