FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDI-TRAK PORTABLE TRACTION DEVICE
K Number: K791396
·
Decision Aug 16, 1979
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
37
Applicant Total
5
Review Days
37
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Basic Information
- Device Name
- MEDI-TRAK PORTABLE TRACTION DEVICE
- K Number
- K791396
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5850
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Medicorp, Inc.
- Date Received
- July 10, 1979
- Decision Date
- August 16, 1979
- Product Code
- HST
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | FDA class 1 | Orthopedic |
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Other Clearances by Medicorp, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860026 | ULTRAMAX III, DIALYZER REPROCESSING DEVICE | Mar 14, 1986 | Substantially Equivalent |
| K844850 | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT | Apr 2, 1985 | Substantially Equivalent |
| K832705 | ULTRAMAX | Jun 25, 1984 | Substantially Equivalent |
| K791164 | NEGATOVE PRESSURE CONVERTOR | Oct 4, 1979 | Substantially Equivalent |