FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
KENDALL CURITY BURN PAD
K Number: K853145
·
Decision Aug 30, 1985
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
16
Applicant Total
63
Review Days
32
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Basic Information
- Device Name
- KENDALL CURITY BURN PAD
- K Number
- K853145
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5180
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- The Kendal Co.
- Date Received
- July 29, 1985
- Decision Date
- August 30, 1985
- Product Code
- FPY
- 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 |
|---|---|---|---|
| FPY | Sheet, Burn | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPY), ordered by most recent decision date.
CP & S STERILE BURN SHEET
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BURNSHIELD TRAUMA DRESSING
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BURNSHIELD FIRE BLANKET
FDA 510(k)
FDA Class 1
·General Hospital
BURN SHEET
FDA 510(k)
FDA Class 1
·General Hospital
BURNS CASUALTY SHEET
FDA 510(k)
FDA Class 1
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BURNS CASUALTY SHEET LIMB WRAP
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by The Kendal Co.
| K Number | Device Name | ||
|---|---|---|---|
| K000087 | MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR | Mar 17, 2000 | Substantially Equivalent |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | Sep 28, 1999 | Substantially Equivalent |
| K991758 | MONOJECT INSULIN SYRINGE | Jun 14, 1999 | Substantially Equivalent |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | Apr 23, 1997 | Substantially Equivalent |
| K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP | Apr 25, 1995 | Substantially Equivalent |
| K942664 | KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM | Jan 17, 1995 | Substantially Equivalent |
| K942774 | POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING | Jul 20, 1994 | Substantially Equivalent for Some Indications |
| K892434 | KENDALL CURITY OXYGEN MASK | Aug 15, 1989 | Substantially Equivalent |
| K892438 | KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES | Jul 24, 1989 | Substantially Equivalent |
| K892440 | KENDALL CURITY EXTENSION TUBES | Jul 24, 1989 | Substantially Equivalent |