The following data is part of a premarket notification filed by Health Line International Corporation (hlic) with the FDA for Health Line International Corporation's Primary Iv Solution Administration Set With Check Valve.
| Device ID | K070630 |
| 510k Number | K070630 |
| Device Name: | HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | HEALTH LINE INTERNATIONAL CORPORATION (HLIC) PO BOX 160435 BLDG E-13 DOOR21 FREEPORT CENTER BLDG Clearfield, UT 84016 |
| Contact | Denice Wroe |
| Correspondent | Denice Wroe HEALTH LINE INTERNATIONAL CORPORATION (HLIC) PO BOX 160435 BLDG E-13 DOOR21 FREEPORT CENTER BLDG Clearfield, UT 84016 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-07 |
| Decision Date | 2007-08-31 |