The following data is part of a premarket notification filed by Solo Pak Laboratories with the FDA for Heparin Lock Flush Solution Usp Kit,100.
| Device ID | K841306 |
| 510k Number | K841306 |
| Device Name: | HEPARIN LOCK FLUSH SOLUTION USP KIT,100 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SOLO PAK LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-30 |
| Decision Date | 1984-06-04 |