The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Meadox Surgimed A/s Catheter Sheath Sys.
| Device ID | K843798 |
| 510k Number | K843798 |
| Device Name: | MEADOX SURGIMED A/S CATHETER SHEATH SYS |
| Classification | Introducer, Catheter |
| Applicant | MEADOX SURGIMED, INC. 103 BAUER DRIVE Oakland , NJ 07436 - |
| Contact | Anthony C Parks |
| Correspondent | Anthony C Parks MEADOX SURGIMED, INC. 103 BAUER DRIVE Oakland , NJ 07436 - |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1984-12-27 |