FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
KIT PAK WET SALINE DRESSING
K Number: K942959
·
Decision Feb 14, 1995
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
13
Review Days
236
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Basic Information
- Device Name
- KIT PAK WET SALINE DRESSING
- K Number
- K942959
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Kit Pak, Inc.
- Date Received
- June 23, 1994
- Decision Date
- February 14, 1995
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Kit Pak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |