The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Sidekick Infusion Kit.
Device ID | K990425 |
510k Number | K990425 |
Device Name: | SIDEKICK INFUSION KIT |
Classification | Pump, Infusion |
Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
Contact | Robert J Bard |
Correspondent | Robert J Bard I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-11 |
Decision Date | 1999-04-23 |
Summary: | summary |