The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Supreme And Response Electrophysiology Catheters.
| Device ID | K161272 |
| 510k Number | K161272 |
| Device Name: | Supreme And Response Electrophysiology Catheters |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | Surgical Instrument Service And Savings Inc (dba Medline ReNewal) 2747 SW 6th St. Redmond, OR 97756 |
| Contact | Brandi J. Panteleon |
| Correspondent | Brandi J. Panteleon Surgical Instrument Service And Savings Inc (dba Medline ReNewal) 2747 SW 6th St. Redmond, OR 97756 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-05 |
| Decision Date | 2017-05-18 |
| Summary: | summary |