FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
KIT PAK DRESSING CHANGE TRAY
K Number: K941499
·
Decision Jul 20, 1994
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
13
Review Days
113
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Basic Information
- Device Name
- KIT PAK DRESSING CHANGE TRAY
- K Number
- K941499
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Kit Pak, Inc.
- Date Received
- March 29, 1994
- Decision Date
- July 20, 1994
- Product Code
- KGX
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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CARE BAND ANTIBACTERIAL BANDAGES
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
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PARALLEL
FDA 510(k)
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Other Clearances by Kit Pak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942959 | KIT PAK WET SALINE DRESSING | Feb 14, 1995 | Substantially Equivalent for Some Indications |
| 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 |
| K923905 | WOUND DRESSING KIT | Jul 2, 1993 | Unknown |
| 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 |