FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FEMORAL CANAL BRUSH
K Number: K810267
·
Decision Feb 9, 1981
Classifications
1
FEI Numbers
1140
Registration Numbers
1140
Same Product Code
57
Applicant Total
48
Review Days
39
Basic Information
- Device Name
- FEMORAL CANAL BRUSH
- K Number
- K810267
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- RICHARD'S MEDICAL EQUIP., INC.
- Date Received
- January 1, 1981
- Decision Date
- February 9, 1981
- Product Code
- LXH
- 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
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Other Clearances by RICHARD'S MEDICAL EQUIP., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC | Jun 16, 1983 | Substantially Equivalent |
| K823837 | RMC TOTAL KNEE SYSTEM | Mar 29, 1983 | Substantially Equivalent |
| K823724 | SPECTRON NECK REPLACEMENT PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP | Mar 9, 1983 | Substantially Equivalent |
| K823723 | SPECTRON PROXIMAL FEMORAL PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823722 | SPECTRON LONG, STRAIGHT FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K823727 | SPECTRON PRIMARY STEM FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K830153 | RICHARDS INTRA-ARTICULAR SHAVER BLADES | Feb 28, 1983 | Substantially Equivalent |
| K830154 | COLLES FRACTURE FRAME | Feb 2, 1983 | Substantially Equivalent |
| K823728 | SPECTRON POLYETHYLENE ACCTUBULAR COMPON | Jan 21, 1983 | Substantially Equivalent |