The following data is part of a premarket notification filed by Neostar Medical Technologies, Inc. with the FDA for Spreadable Sheath Introducer Set.
| Device ID | K960625 |
| 510k Number | K960625 |
| Device Name: | SPREADABLE SHEATH INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | NEOSTAR MEDICAL TECHNOLOGIES, INC. 100 ROSS RD. King Of Prussia, PA 19406 |
| Contact | David W Weaver Iii |
| Correspondent | David W Weaver Iii NEOSTAR MEDICAL TECHNOLOGIES, INC. 100 ROSS RD. King Of Prussia, PA 19406 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-13 |
| Decision Date | 1996-08-08 |