FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLINIGUARD
K Number: K800527
·
Decision May 8, 1980
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
16
Review Days
62
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Basic Information
- Device Name
- CLINIGUARD
- K Number
- K800527
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Clinipad Corp.
- Date Received
- March 7, 1980
- Decision Date
- May 8, 1980
- Product Code
- KMF
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
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Other Clearances by Clinipad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931560 | CARDIAC CATHETERIZATION TRAY | Jul 11, 1994 | Unknown |
| K931668 | PICC INSERTION TRAY | Mar 7, 1994 | Unknown |
| K932071 | I.V. START KIT | Feb 17, 1994 | Unknown |
| K932010 | V.A.D. ACCESS KIT | Feb 3, 1994 | Substantially Equivalent |
| K932036 | LACERATION TRAY | Dec 13, 1993 | Unknown |
| K932016 | TRACHEOSTOMY CARE TRAY | Nov 3, 1993 | Substantially Equivalent |
| K862562 | PUNCH BIOPSY KIT | Oct 7, 1986 | Substantially Equivalent |
| K862563 | TRACHEOSTOMY CLEANSING SOLUTION | Jul 15, 1986 | Substantially Equivalent |
| K833075 | WET DRESSING KIT | Jan 27, 1984 | Substantially Equivalent |
| K833432 | CATHETER INSERTION KIT | Dec 28, 1983 | Substantially Equivalent |