FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTERNAL INCONTINENCE CATHETER SET-NON
K Number: K832108
·
Decision Jul 18, 1983
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
16
Review Days
19
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Basic Information
- Device Name
- EXTERNAL INCONTINENCE CATHETER SET-NON
- K Number
- K832108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Plasco, Inc.
- Date Received
- June 29, 1983
- Decision Date
- July 18, 1983
- Product Code
- KNX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Plasco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980066 | CPR FILTERSHIELD | Jul 16, 1998 | Substantially Equivalent |
| K953414 | CPR MICROMASK WITH OXYGEN INLET | Mar 20, 1996 | Substantially Equivalent |
| K951483 | CPR MICROMASK | Oct 19, 1995 | Substantially Equivalent |
| K950769 | CPR MICROMASK PLUS CATALOG NO 73-402 | Mar 10, 1995 | Substantially Equivalent |
| K950770 | CPR MICROSHIELD II | Mar 10, 1995 | Substantially Equivalent |
| K943386 | CPR MICROMASK | Feb 21, 1995 | Substantially Equivalent |
| K932649 | PHARMAFEED | Nov 16, 1993 | Substantially Equivalent |
| K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | Apr 14, 1988 | Substantially Equivalent |
| K870623 | ENTERAL ADMINISTRATION SET | Jun 26, 1987 | Substantially Equivalent |
| K870019 | THE LAHR BALLOON | Apr 1, 1987 | Substantially Equivalent |