The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg Bag.
| Device ID | K972887 |
| 510k Number | K972887 |
| Device Name: | MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Christine Galea |
| Correspondent | Christine Galea MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-05 |
| Decision Date | 1997-12-11 |
| Summary: | summary |