The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Prismaflo Ii.
| Device ID | K082758 |
| 510k Number | K082758 |
| Device Name: | PRISMAFLO II |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Stephen T Mlcoch |
| Correspondent | Stephen T Mlcoch STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-19 |
| Decision Date | 2008-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260114149897 | K082758 | 000 |