The following data is part of a premarket notification filed by Cane Srl with the FDA for Microjet Crono Pca.
Device ID | K013822 |
510k Number | K013822 |
Device Name: | MICROJET CRONO PCA |
Classification | Pump, Infusion, Pca |
Applicant | CANE SRL P.O. BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm, Pe |
Correspondent | Daniel Kamm, Pe CANE SRL P.O. BOX 7007 Deerfield, IL 60015 |
Product Code | MEA |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-16 |
Decision Date | 2002-05-08 |
Summary: | summary |