The following data is part of a premarket notification filed by Specialized Health Products International, Inc. with the FDA for Safestep Max Power-injectable Infusion Set.
| Device ID | K073050 |
| 510k Number | K073050 |
| Device Name: | SAFESTEP MAX POWER-INJECTABLE INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. 585 WEST 500 SOUTH Bountiful, UT 84010 |
| Contact | Mark Nelson |
| Correspondent | Mark Nelson SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. 585 WEST 500 SOUTH Bountiful, UT 84010 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-29 |
| Decision Date | 2008-01-25 |
| Summary: | summary |