Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

Scalpel, Ultrasonic, Reprocessed

Surgical Instrument Service And Savings Inc

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.

Pre-market Notification Details

Device IDK173627
510k NumberK173627
Device Name:Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
ClassificationScalpel, Ultrasonic, Reprocessed
Applicant Surgical Instrument Service And Savings Inc dba Medline ReNewal 1500 NE Hemlock Ave Redmond,  OR  97756
ContactStephanie Boyle Mays
CorrespondentStephanie Boyle Mays
Surgical Instrument Service And Savings Inc dba Medline ReNewal 1500 NE Hemlock Ave Redmond,  OR  97756
Product CodeNLQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-24
Decision Date2018-07-12
Summary:summary

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