The following data is part of a premarket notification filed by I-flow Corp. with the FDA for On-q, Painbuster, C-bloc, Select-a-flow, Ondemand, Homepump, Eclipse, C-series, One-step Kvo, Easypump.
Device ID | K063530 |
510k Number | K063530 |
Device Name: | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP |
Classification | Pump, Infusion, Elastomeric |
Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
Contact | James J Dal Porto |
Correspondent | James J Dal Porto 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 | 2006-11-22 |
Decision Date | 2007-01-26 |
Summary: | summary |