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 Impact Open Sealer/divider.
| Device ID | K153745 |
| 510k Number | K153745 |
| Device Name: | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN 2747 SW 6TH ST. Redmond, OR 97756 |
| Contact | Brandi J. Panteleon |
| Correspondent | Brandi J. Panteleon SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN 2747 SW 6TH ST. 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 | 2015-12-29 |
| Decision Date | 2016-05-02 |
| Summary: | summary |