The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for External Leg Bag.
| Device ID | K901219 |
| 510k Number | K901219 |
| Device Name: | EXTERNAL LEG BAG |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Contact | L Laemmar |
| Correspondent | L Laemmar ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-06-27 |