The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Model 113 Treonic Ip3 Digital Syringe Pu.
Device ID | K790945 |
510k Number | K790945 |
Device Name: | MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU |
Classification | Pump, Infusion |
Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-18 |
Decision Date | 1979-06-01 |