The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc (dba Medline Ren with the FDA for Medline Renewal Reprocessed Sonicision Cordless Ultrasonic Dissector.
| Device ID | K170955 |
| 510k Number | K170955 |
| Device Name: | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Redmond, OR 97756 |
| Contact | Brandi Panteleon |
| Correspondent | Brandi Panteleon Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Redmond, OR 97756 |
| Product Code | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-07-03 |
| Summary: | summary |