The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Gent-l-kare Sterile Urinary Leg Bag.
| Device ID | K881217 |
| 510k Number | K881217 |
| Device Name: | GENT-L-KARE STERILE URINARY LEG BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn, WI 53121 |
| Contact | Gary L Swanson |
| Correspondent | Gary L Swanson GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn, WI 53121 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-07-29 |