The following data is part of a premarket notification filed by Adam Spence Corp. with the FDA for Ez-intro Percutaneous Catheter Sheath, Ez-intro Vessel Dilator.
| Device ID | K983940 |
| 510k Number | K983940 |
| Device Name: | EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR |
| Classification | Introducer, Catheter |
| Applicant | ADAM SPENCE CORP. 1746 RT. 34 P.O. BOX 1467 Wall, NJ 07719 |
| Contact | Carol Rosenbloom |
| Correspondent | Carol Rosenbloom ADAM SPENCE CORP. 1746 RT. 34 P.O. BOX 1467 Wall, NJ 07719 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-05 |
| Decision Date | 1999-07-15 |
| Summary: | summary |