Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

Laparoscope, General & Plastic Surgery, 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 Carter-thomason Needle Point Suture Passer.

Pre-market Notification Details

Device IDK182828
510k NumberK182828
Device Name:Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
ClassificationLaparoscope, General & Plastic Surgery, 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 CodeNLM  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-05
Decision Date2019-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20193489000631 K182828 000

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