FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPROVED KNEE DRESSING
K Number: K760573
·
Decision Oct 5, 1976
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
4
Applicant Total
48
Review Days
32
Basic Information
- Device Name
- IMPROVED KNEE DRESSING
- K Number
- K760573
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- RICHARD'S MEDICAL EQUIP., INC.
- Date Received
- September 3, 1976
- Decision Date
- October 5, 1976
- Product Code
- ITM
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ITM | Cage, Knee | FDA class 1 | Physical Medicine |
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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 |