510(k) K972887
- Device
- MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
- Applicant
- MEDLINE INDUSTRIES, INC.
- 510(k) number
- K972887
- Product code
- KNX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-11
- Date received
- 1997-08-05
- Regulation
- 876.5250
- Classification name
- Collector, Urine, (and Accessories) For Indwelling Catheter
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE GALEA
- Address
- One Medline Pl. Mundelein IL US 60060 60060
FDA Registration Numbers#
- 3033796870
- 3012050423
- 2024311
- 1423537
- 3010844918
- 2029275
- 3011987967
- 3006538822
- 3014656749
- 3015009174
- 3034669683
- 3033796310
- 3007289408
- 3031190571
- 3038624153
- 3010400865
- 3016685983
- 3003717263
- 3005636544
- 3012568936
- 1420054
- 2032112
- 3002907620
- 9616088
- 3016884033
- 2433012
- 3019798849
- 1018233
- 3013522936
- 3022866893
- 3008467060
- 1054241
- 3026818268
- 3043051314
- 3030511423
- 3006552462
- 3016763307
- 3012445205
- 9611665
- 3010149039
- 3015479927
- 3017896419
- 3003755374
- 3011707784
- 3010594263
- 2029015
- 3002504068
- 1921846
- 3013429557
- 3016171914
- 9611590
- 1055236
- 3004111573
- 3011814545
- 3008806809
- 1643817
- 3014200871
- 3009337401
- 9680222
- 3011020307
- 1061124
- 9612030
- 3005273623
- 3012251300
- 3004365956
- 3010291427
- 3015821396
- 3043619925
- 3009888344
- 2249651
- 2320762
- 1043214
- 3009104075
- 3010806410
- 3008294723
- 3007007790
- 3006611221
- 1043646
- 3014637079
Source Documents#
Other 510(k) Records For Product Code KNX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110518 | IBAG | Future Path Medical, LLC | 2011-06-24 |
| K973364 | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | Maersk Medical A/S | 1998-03-17 |
| K971271 | BESECURE EXTERNAL URINARY COLLECTION SYSTEM | Urology Research Intl., Inc. | 1997-08-18 |
| K971929 | AMSINO URINARY LEG BAG | Amsino Intl., Inc. | 1997-08-06 |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Welcon, Inc. | 1997-07-29 |
| K964690 | LIBERTY VALVE | Cleveland Medical Devices, Inc. | 1997-03-21 |
| K964745 | AMSINO URINARY DRAINAGE BAG | Amsino Intl., Inc. | 1997-03-18 |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | Customed, Inc. | 1996-10-04 |
| K960949 | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | Bristol-Myers Squibb | 1996-04-19 |
| K952208 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-08-15 |
| K944377 | ORION'S URINARY DRAINAGE SET | Regulatory & Marketing Services, Inc. | 1994-12-06 |
| K944236 | NEEDLELESS URINE SAMPLING PORT | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-11-16 |
| K940206 | BARD URINE COLLECTION PRODUCTS MODIFICATION | C.R. Bard, Inc. | 1994-09-16 |
| K941447 | SIMPLA S4, S5, S7 | Simpla Plastics , Ltd. | 1994-07-18 |
| K935557 | URINARY DRAINAGE BAG | Puritas Health Care, Inc. | 1994-03-07 |
Legacy Summary#
summary
FDA Review#
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