Medline ReNewal Reprocessed Harmonic ACE+7 Shears

Scalpel, Ultrasonic, Reprocessed

Surgical Instrument Service And Savings Inc (dba Medline ReN

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 Harmonic Ace+7 Shears.

Pre-market Notification Details

Device IDK193563
510k NumberK193563
Device Name:Medline ReNewal Reprocessed Harmonic ACE+7 Shears
ClassificationScalpel, Ultrasonic, Reprocessed
Applicant Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Ave Redmond,  OR  97756
ContactGail Gassner
CorrespondentGail Gassner
Surgical Instrument Service And Savings Inc (dba Medline ReN 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 Received2019-12-23
Decision Date2020-08-19

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