The following data is part of a premarket notification filed by Palco Laboratories, Inc. with the FDA for Palco Labs Loadmatic.
| Device ID | K913694 |
| 510k Number | K913694 |
| Device Name: | PALCO LABS LOADMATIC |
| Classification | Syringe, Piston |
| Applicant | PALCO LABORATORIES, INC. 8030 SOQUEL AVE. Santa Cruz, CA 95062 |
| Contact | Paul D Levin |
| Correspondent | Paul D Levin PALCO LABORATORIES, INC. 8030 SOQUEL AVE. Santa Cruz, CA 95062 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1991-12-17 |