The following data is part of a premarket notification filed by Lsl Industries, Inc. with the FDA for Urinary Drain Bag, Lsl Cat. No. 1425 And 1450.
| Device ID | K882714 |
| 510k Number | K882714 |
| Device Name: | URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 |
| Classification | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Applicant | LSL INDUSTRIES, INC. 7383 NORTH ROGERS AVE. Chicago, IL 60626 |
| Contact | Ash Luthra |
| Correspondent | Ash Luthra LSL INDUSTRIES, INC. 7383 NORTH ROGERS AVE. Chicago, IL 60626 |
| Product Code | EYZ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-01 |
| Decision Date | 1989-01-31 |