The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Conveen Leg Bag Strap.
| Device ID | K953783 |
| 510k Number | K953783 |
| Device Name: | CONVEEN LEG BAG STRAP |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Contact | Mary Lee Lewis |
| Correspondent | Mary Lee Lewis 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 | 1995-08-14 |
| Decision Date | 1995-09-13 |