FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHARMA-PLAST URINARY DRAINAGE BAG 2000
K Number: K843480
·
Decision Oct 11, 1984
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
17
Review Days
35
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Basic Information
- Device Name
- PHARMA-PLAST URINARY DRAINAGE BAG 2000
- K Number
- K843480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Zimmar Consulting , Ltd.
- Date Received
- September 6, 1984
- Decision Date
- October 11, 1984
- 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 |
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Other Clearances by Zimmar Consulting , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K860322 | CLINISET INFUSION SET | Apr 7, 1986 | Substantially Equivalent |
| K843477 | PHARMA-PLAST RECTAL TIP | Dec 5, 1984 | Substantially Equivalent |
| K843478 | PHARMA-PLAST URIDROP-URIDOME | Dec 5, 1984 | Substantially Equivalent |
| K843468 | PHARMA-PLAST SUCTION SET TYPE YANKAUER | Nov 23, 1984 | Substantially Equivalent |
| K843469 | PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- | Nov 19, 1984 | Substantially Equivalent |
| K843466 | PHARMA-PLAST OXYGEN CATHETER | Nov 19, 1984 | Substantially Equivalent |
| K843467 | PHARMA-PLAST NASAL OXYGEN CANNULA | Nov 19, 1984 | Substantially Equivalent |
| K843470 | PHARMA-PLAST CONNECTING TUBE TYPE SUCT- | Nov 16, 1984 | Substantially Equivalent |
| K843475 | PHARMA-PLAST SINGLE USE OVERSHOES | Oct 31, 1984 | Substantially Equivalent |
| K843471 | PHARMA-PLAST SYRINGE | Oct 31, 1984 | Substantially Equivalent |