The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Homepump, Eclipse, C-series, Painbuster, C-bloc, On-q, Easypump, One Step Kvo.
Device ID | K020660 |
510k Number | K020660 |
Device Name: | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO |
Classification | Pump, Infusion, Elastomeric |
Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
Contact | Shane Noehre |
Correspondent | Shane Noehre I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
Product Code | MEB |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-01 |
Decision Date | 2002-03-20 |
Summary: | summary |