FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MMG DISPOSABLE URINARY LEG BAG
K Number: K800694
·
Decision May 30, 1980
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
11
Review Days
64
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Basic Information
- Device Name
- MMG DISPOSABLE URINARY LEG BAG
- K Number
- K800694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Marketing Group
- Date Received
- March 27, 1980
- Decision Date
- May 30, 1980
- 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
Other 510(k) clearances with the same product code (KNX), ordered by most recent decision date.
IBAG
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4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
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MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
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BESECURE EXTERNAL URINARY COLLECTION SYSTEM
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AMSINO URINARY LEG BAG
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WELCON HUE-VU URINARY DRAINAGE BAG
FDA 510(k)
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Other Clearances by Medical Marketing Group
| K Number | Device Name | ||
|---|---|---|---|
| K910022 | MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT | Apr 2, 1991 | Unknown |
| K884819 | O'NEIL URINARY CATHETER INTRODUCER | Feb 17, 1989 | Substantially Equivalent |
| K874682 | MMG CATHETER PLUG W/DRAINAGE TUBE COVER | Jan 27, 1988 | Substantially Equivalent |
| K871999 | MMG URO-SELF CATHETER | Aug 25, 1987 | Substantially Equivalent |
| K863912 | THE MMG 5 IN 1 CONNECTOR | Oct 27, 1986 | Substantially Equivalent |
| K840838 | MMG CONNECTIVE TUBING | Mar 30, 1984 | Substantially Equivalent |
| K821168 | DISPOSABLE URINARY LEGBAG W/STRAP | May 24, 1982 | Substantially Equivalent |
| K811469 | MMG URINARY DRAINAGE TUBING | Jun 12, 1981 | Substantially Equivalent |
| K791847 | ASPRI-LUKE | Oct 2, 1979 | Substantially Equivalent |
| K790279 | CATHETER, MMG LATEX EXTERNAL | Mar 6, 1979 | Substantially Equivalent |