The following data is part of a premarket notification filed by Intl. Medication Systems, Ltd. with the FDA for Sterile Empty Pca Syringe.
| Device ID | K945797 |
| 510k Number | K945797 |
| Device Name: | STERILE EMPTY PCA SYRINGE |
| Classification | Syringe, Piston |
| Applicant | INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
| Contact | David B Barry |
| Correspondent | David B Barry INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-05-19 |