The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Sidekick 50 Plus And Sidekick 100 Plus.
Device ID | K923875 |
510k Number | K923875 |
Device Name: | SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS |
Classification | Pump, Infusion |
Applicant | I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
Contact | Robert J Bard |
Correspondent | Robert J Bard I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-03 |
Decision Date | 1993-05-13 |