The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Veni-gard I.v. Dressing.
| Device ID | K935389 |
| 510k Number | K935389 |
| Device Name: | CONMED VENI-GARD I.V. DRESSING |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405014642 | K935389 | 000 |
| 20653405014420 | K935389 | 000 |
| 20653405014277 | K935389 | 000 |
| 20653405014260 | K935389 | 000 |