The following data is part of a premarket notification filed by Specialized Health Products, Intl. with the FDA for Miniloc Safety Infusion Set.
| Device ID | K050600 |
| 510k Number | K050600 |
| Device Name: | MINILOC SAFETY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | SPECIALIZED HEALTH PRODUCTS, INTL. 585 WEST 500 SOUTH SUITE 200 Bountiful, UT 84010 |
| Contact | Mark Nelson |
| Correspondent | Mark Nelson SPECIALIZED HEALTH PRODUCTS, INTL. 585 WEST 500 SOUTH SUITE 200 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 | 2005-03-09 |
| Decision Date | 2005-05-12 |
| Summary: | summary |