The following data is part of a premarket notification filed by Surgical Instrument Services And Savings, Inc with the FDA for Medline Renewal Reprocessed Endopath Endoscopic Instruments.
| Device ID | K152313 |
| 510k Number | K152313 |
| Device Name: | Medline ReNewal Reprocessed Endopath Endoscopic Instruments |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Surgical Instrument Services And Savings, Inc 2747 SW 6th St. Redmond, OR 97756 |
| Contact | Brandi J Panteleon |
| Correspondent | Brandi J Panteleon Surgical Instrument Services And Savings, Inc 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 | 2015-08-17 |
| Decision Date | 2016-01-06 |
| Summary: | summary |