K060352 is an FDA 510(k) clearance for the HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Health Line International Corporation (Clearfield, US). The FDA issued a Cleared decision on May 31, 2006, 107 days after receiving the submission on February 13, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K060352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2006 |
| Decision Date | May 31, 2006 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |