FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BODILY FLUID DISPOSAL KIT
K Number: K944880
·
Decision Dec 15, 1994
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
14
Review Days
73
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Basic Information
- Device Name
- BODILY FLUID DISPOSAL KIT
- K Number
- K944880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Resources, Inc.
- Date Received
- October 3, 1994
- Decision Date
- December 15, 1994
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
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KP Protective Face Mask
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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 |
| K941469 | IV START KIT | May 12, 1994 | Substantially Equivalent |
| K941468 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | May 12, 1994 | Substantially Equivalent |
| K941471 | CENTRAL LINE DRESSING CHANGE TRAY | May 12, 1994 | Substantially Equivalent |