FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIALYSIS TRAY
K Number: K841124
·
Decision Apr 20, 1984
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
20
Review Days
36
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Basic Information
- Device Name
- DIALYSIS TRAY
- K Number
- K841124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medcare Products
- Date Received
- March 15, 1984
- Decision Date
- April 20, 1984
- Product Code
- KOC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
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BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
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Other Clearances by Medcare Products
| K Number | Device Name | ||
|---|---|---|---|
| K841122 | TRACHEOSTOMY CARE TRAY | Apr 25, 1984 | Substantially Equivalent |
| K841123 | DRESSING CHANGE TRAY | Apr 17, 1984 | Substantially Equivalent |
| K831374 | MED CARE PREP RAZOR | Oct 4, 1983 | Substantially Equivalent |
| K831663 | TISSUE FORCEPS | Sep 26, 1983 | Substantially Equivalent |
| K831664 | PLASTIC THUMB FORCEPS | Sep 12, 1983 | Substantially Equivalent |
| K831665 | DISPOSABLE NEEDLE HOLDER | Sep 12, 1983 | Substantially Equivalent |
| K831661 | DISPOSABLE SCISSORS | Aug 25, 1983 | Substantially Equivalent |
| K831662 | DISPOSABLE HEMOSTAT (STRAIGHT&CURVED | Jul 19, 1983 | Substantially Equivalent |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Mar 31, 1983 | Substantially Equivalent |
| K823853 | MEDCARE WOUND CLOSURE TRAY | Jan 14, 1983 | Substantially Equivalent |