FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRESSING CHANGE TRAY
K Number: K841123
·
Decision Apr 17, 1984
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
20
Review Days
33
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Basic Information
- Device Name
- DRESSING CHANGE TRAY
- K Number
- K841123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medcare Products
- Date Received
- March 15, 1984
- Decision Date
- April 17, 1984
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by Medcare Products
| K Number | Device Name | ||
|---|---|---|---|
| K841122 | TRACHEOSTOMY CARE TRAY | Apr 25, 1984 | Substantially Equivalent |
| K841124 | DIALYSIS TRAY | Apr 20, 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 |