The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Corgrip.
Device ID | K133599 |
510k Number | K133599 |
Device Name: | CORGRIP |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CORPAK MEDSYSTEMS 1001 ASBURY DR Buffalo Grove, IL 60089 -0000 |
Contact | Stephanie Wasielewski |
Correspondent | Stephanie Wasielewski CORPAK MEDSYSTEMS 1001 ASBURY DR Buffalo Grove, IL 60089 -0000 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-25 |
Decision Date | 2014-03-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CORGRIP 86212709 4851940 Live/Registered |
AVENT, INC. 2014-03-06 |
CORGRIP 86142408 4685795 Live/Registered |
AVENT, INC. 2013-12-12 |
CORGRIP 75065042 2104147 Dead/Cancelled |
HARSCO TECHNOLOGIES CORPORATION 1996-02-28 |