The following data is part of a premarket notification filed by Surgical Instrument Services And Savings, Inc with the FDA for Medline Renewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/divider.
Device ID | K162751 |
510k Number | K162751 |
Device Name: | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider |
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 | 2016-09-30 |
Decision Date | 2017-05-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20888277664170 | K162751 | 000 |