FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTHROSCOPIC LEG HOLDER 434-21
K Number: K834076
·
Decision Dec 27, 1983
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
13
Review Days
32
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Basic Information
- Device Name
- ARTHROSCOPIC LEG HOLDER 434-21
- K Number
- K834076
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Custom Medical Products, Ltd.
- Date Received
- November 25, 1983
- Decision Date
- December 27, 1983
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Custom Medical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K931417 | STERILE EQUIPMENT COVERS | Jul 6, 1995 | Substantially Equivalent |
| K931456 | SURGICAL DRAPE AND GOWN TRAY | Jul 8, 1994 | Substantially Equivalent |
| K931418 | SURGICAL DRAPE | May 5, 1994 | Substantially Equivalent |
| K931455 | HEAD SHEET | May 5, 1994 | Substantially Equivalent |
| K930815 | ABDOMINAL / THORACIC PATIENT DRAPE | May 5, 1994 | Substantially Equivalent |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | Jan 25, 1994 | Unknown |
| K926519 | SURGICAL GOWN | Aug 12, 1993 | Substantially Equivalent |
| K900847 | ENEMA KIT 'Y' DESIGN | Apr 13, 1990 | Substantially Equivalent |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | Apr 13, 1990 | Substantially Equivalent |
| K895084 | APERTURE | Oct 27, 1989 | Substantially Equivalent |