Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

Scalpel, Ultrasonic, Reprocessed

Sterilmed, Inc.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Focus Shears + Adaptive Tissue Technology.

Pre-market Notification Details

Device IDK190610
510k NumberK190610
Device Name:Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
ClassificationScalpel, Ultrasonic, Reprocessed
Applicant Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth,  MN  55446
ContactJan Flegeau
CorrespondentJan Flegeau
Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth,  MN  55446
Product CodeNLQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-11
Decision Date2019-08-15

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