The following data is part of a premarket notification filed by Cure Medical Llc. with the FDA for Cure Catheter.
Device ID | K110653 |
510k Number | K110653 |
Device Name: | CURE CATHETER |
Classification | Catheter, Straight |
Applicant | CURE MEDICAL LLC. 3722 AVENUE SAUSALITO Irvine, CA 92606 |
Contact | Robyn Scopis |
Correspondent | Robyn Scopis CURE MEDICAL LLC. 3722 AVENUE SAUSALITO Irvine, CA 92606 |
Product Code | EZD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-07 |
Decision Date | 2011-08-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20815947020288 | K110653 | 000 |
20815947020271 | K110653 | 000 |
20815947020264 | K110653 | 000 |
20815947020257 | K110653 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CURE CATHETER 86125386 4591923 Live/Registered |
Cure Medical, LLC 2013-11-21 |
CURE CATHETER 78348044 3110064 Live/Registered |
CURE MEDICAL LLC 2004-01-06 |