The following data is part of a premarket notification filed by Cmed with the FDA for Stable Flow.
Device ID | K981157 |
510k Number | K981157 |
Device Name: | STABLE FLOW |
Classification | Set, Administration, Intravascular |
Applicant | CMED 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Greg Holland |
Correspondent | Greg Holland CMED 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-31 |
Decision Date | 1998-06-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STABLE FLOW 78967752 not registered Dead/Abandoned |
Innovative Fluid Systems Inc. 2006-09-06 |
STABLE FLOW 78963879 3410970 Dead/Cancelled |
Proton Energy Systems, Inc. 2006-08-30 |