The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Sonicision Cordless Ultrasonic Dissector.
Device ID | K173627 |
510k Number | K173627 |
Device Name: | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
Classification | Scalpel, Ultrasonic, Reprocessed |
Applicant | Surgical Instrument Service And Savings Inc dba Medline ReNewal 1500 NE Hemlock Ave Redmond, OR 97756 |
Contact | Stephanie Boyle Mays |
Correspondent | Stephanie Boyle Mays Surgical Instrument Service And Savings Inc dba Medline ReNewal 1500 NE Hemlock Ave 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 | 2017-11-24 |
Decision Date | 2018-07-12 |
Summary: | summary |