FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURAD MEDICATED PLASTIC STRIPS
K Number: K872310
·
Decision Aug 28, 1987
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
63
Review Days
74
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Basic Information
- Device Name
- CURAD MEDICATED PLASTIC STRIPS
- K Number
- K872310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- The Kendal Co.
- Date Received
- June 15, 1987
- Decision Date
- August 28, 1987
- Product Code
- CGX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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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 |