The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Conveen Urine Bag - Sterile.
| Device ID | K955609 |
| 510k Number | K955609 |
| Device Name: | CONVEEN URINE BAG - STERILE |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Contact | M. Sydney Lilly |
| Correspondent | M. Sydney Lilly COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1995-12-29 |