The following data is part of a premarket notification filed by Specialized Health Products, Inc. with the FDA for Secureloc; Advancintroducer.
| Device ID | K050023 |
| 510k Number | K050023 |
| Device Name: | SECURELOC; ADVANCINTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | SPECIALIZED HEALTH PRODUCTS, INC. 585 WEST 500 SOUTH Bountiful, UT 84010 |
| Contact | Mark Nelson |
| Correspondent | Mark Nelson SPECIALIZED HEALTH PRODUCTS, INC. 585 WEST 500 SOUTH Bountiful, UT 84010 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-05 |
| Decision Date | 2005-02-18 |
| Summary: | summary |