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 |