The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Health Line International Corporations,s Iv Administrative Sets.
| Device ID | K060352 |
| 510k Number | K060352 |
| Device Name: | HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | HEALTH LINE INTERNATIONAL CORPORATION FREEPORT CENTER BLDG E-13 DR 2 PO BOX 160435 Clearfield, UT 84016 -0435 |
| Contact | Jack Speer |
| Correspondent | Jack Speer HEALTH LINE INTERNATIONAL CORPORATION FREEPORT CENTER BLDG E-13 DR 2 PO BOX 160435 Clearfield, UT 84016 -0435 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-05-31 |
| Summary: | summary |