FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRAL LINE DRESSING CHANGE TRAY
K Number: K941471
·
Decision May 12, 1994
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
14
Review Days
45
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Basic Information
- Device Name
- CENTRAL LINE DRESSING CHANGE TRAY
- K Number
- K941471
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Resources, Inc.
- Date Received
- March 28, 1994
- Decision Date
- May 12, 1994
- 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 Clinical Resources, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941470 | TRACHEOSTOMY CARE KIT | Feb 14, 1995 | Unknown |
| K944882 | IRRIGATION TRAY | Jan 12, 1995 | Substantially Equivalent |
| K944881 | SKIN SCRUB TRAY | Dec 27, 1994 | Unknown |
| K944879 | GAUZE SPONGES | Dec 23, 1994 | Substantially Equivalent |
| K945021 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K945019 | FLUFF GAUXZE ROLL | Dec 23, 1994 | Substantially Equivalent |
| K945020 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K944880 | BODILY FLUID DISPOSAL KIT | Dec 15, 1994 | Substantially Equivalent |
| K941469 | IV START KIT | May 12, 1994 | Substantially Equivalent |
| K941468 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | May 12, 1994 | Substantially Equivalent |