The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Conveen Easicath Set.
| Device ID | K973070 |
| 510k Number | K973070 |
| Device Name: | CONVEEN EASICATH SET |
| Classification | Catheter, Straight |
| Applicant | COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Contact | Sydney Lilly |
| Correspondent | Sydney Lilly COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932640633 | K973070 | 000 |
| 05708932640404 | K973070 | 000 |
| 05708932640381 | K973070 | 000 |
| 05708932640367 | K973070 | 000 |
| 05708932640350 | K973070 | 000 |
| 05708932639828 | K973070 | 000 |
| 05708932639804 | K973070 | 000 |
| 05708932639798 | K973070 | 000 |
| 05708932639781 | K973070 | 000 |
| 05708932639774 | K973070 | 000 |
| 05708932640411 | K973070 | 000 |
| 05708932640428 | K973070 | 000 |
| 05708932640640 | K973070 | 000 |
| 05708932640671 | K973070 | 000 |
| 05708932640664 | K973070 | 000 |
| 05708932615884 | K973070 | 000 |
| 05708932640619 | K973070 | 000 |
| 05708932640596 | K973070 | 000 |
| 05708932640343 | K973070 | 000 |
| 05708932640336 | K973070 | 000 |
| 05708932639835 | K973070 | 000 |
| 05708932639767 | K973070 | 000 |