PRISMAFLO
Accessories, Blood Circuit, Hemodialysis
STIHLER ELECTRONIC GMBH
The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Prismaflo.
Pre-market Notification Details
| Device ID | K020103 |
| 510k Number | K020103 |
| Device Name: | PRISMAFLO |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzilloto |
| Correspondent | Richard C Lanzilloto STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-11 |
| Decision Date | 2002-07-24 |
Trademark Results [PRISMAFLO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISMAFLO 78248733 2825277 Dead/Cancelled |
Gambro Lundia AB 2003-05-12 |
 PRISMAFLO 78248694 2825276 Live/Registered |
Gambro Lundia AB 2003-05-12 |
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