FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
WOUND DRESSING KIT
K Number: K923905
·
Decision Jul 2, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
23
Applicant Total
13
Review Days
332
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Basic Information
- Device Name
- WOUND DRESSING KIT
- K Number
- K923905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Kit Pak, Inc.
- Date Received
- August 4, 1992
- Decision Date
- July 2, 1993
- Product Code
- MCY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCY), ordered by most recent decision date.
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
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CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
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FDA Class 2
·General Hospital
WOUND CARE COMPRESSION SYSTEM (WCCS)
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FDA Class 2
·General Hospital
DRESSING CHANGE TRAY
FDA 510(k)
FDA Class 2
·General Hospital
CIRCULON SYSTEM STEP 1
FDA 510(k)
FDA Class 2
·General Hospital
CIRCULON SYSTEM STEP 2
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Kit Pak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942959 | KIT PAK WET SALINE DRESSING | Feb 14, 1995 | Substantially Equivalent for Some Indications |
| K941499 | KIT PAK DRESSING CHANGE TRAY | Jul 20, 1994 | Unknown |
| K932310 | KIT PAK INCONTINENT SKIN CARE KIT | Jun 1, 1994 | Unknown |
| K934080 | URINARY DRAINAGE BAG | May 18, 1994 | Substantially Equivalent |
| K931013 | FOLEY CATHETER TRAY | Aug 9, 1993 | Substantially Equivalent |
| K924051 | KIT PAK I.V. START KIT | Jun 22, 1993 | Unknown |
| K923906 | FOLEY INSERTION TRAY | Jun 22, 1993 | Unknown |
| K922051 | KIT PAK'S FLUSHING KIT | Jun 17, 1993 | Unknown |
| K925281 | KIT PAK URINARY CARE SUPPLIES | Apr 19, 1993 | Unknown |
| K900148 | KIT PAK IRRIGATION TRAY | Apr 23, 1990 | Unknown |