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 |