FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
WRIST TRACTION
K Number: K926069
·
Decision Jan 21, 1993
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
13
Review Days
51
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Basic Information
- Device Name
- WRIST TRACTION
- K Number
- K926069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Octostop, Inc.
- Date Received
- December 1, 1992
- Decision Date
- January 21, 1993
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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| K953246 | OCTOROLL | Sep 29, 1995 | Substantially Equivalent |
| K952871 | RIDGES PLUS | Jul 20, 1995 | Substantially Equivalent |
| K942916 | OCTOPAQUE UNIVERSAL | Sep 8, 1994 | Substantially Equivalent |
| K940306 | OCTOSTOP COMPENSATING FILTERS | Sep 6, 1994 | Substantially Equivalent |
| K935444 | OCTOSTOP(R) CHAIR (NEW MODEL | Sep 2, 1994 | Substantially Equivalent |
| K930124 | VARIANT OF OCTOSTOP AND OCTOPAQUE | Feb 9, 1994 | Substantially Equivalent |
| K930357 | ACCESSORY TO UNIVERSAL OCTOPAQUE | Jul 13, 1993 | Substantially Equivalent |
| K913659 | LITTLE PRISM | Oct 14, 1992 | Substantially Equivalent |