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 Ligasure Maryland Jaw Sealer/divider.
| Device ID | K182588 |
| 510k Number | K182588 |
| Device Name: | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Contact | Stephanie Boyle Mays |
| Correspondent | Stephanie Boyle Mays Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-20 |
| Decision Date | 2018-10-31 |
| Summary: | summary |