The following data is part of a premarket notification filed by Solo Pak Laboratories with the FDA for Heparin Lock Flush Procedure Pack.
| Device ID | K841166 |
| 510k Number | K841166 |
| Device Name: | HEPARIN LOCK FLUSH PROCEDURE PACK |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SOLO PAK LABORATORIES Franklin Park , IL 60131 - |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-06-04 |