The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Conveen(r) Leg-bag (600 Ml).
| Device ID | K871643 |
| 510k Number | K871643 |
| Device Name: | CONVEEN(R) LEG-BAG (600 ML) |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard Hamer |
| Correspondent | Richard Hamer COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-27 |
| Decision Date | 1987-06-10 |