FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKIN SCRUB KIT
K Number: K890570
·
Decision May 5, 1989
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
13
Review Days
88
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Basic Information
- Device Name
- SKIN SCRUB KIT
- K Number
- K890570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kit Pak, Inc.
- Date Received
- February 6, 1989
- Decision Date
- May 5, 1989
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |