SignalMark Lung Biopsy Site Marker

Staple, Implantable

ViewPoint Medical, Inc.

The following data is part of a premarket notification filed by Viewpoint Medical, Inc. with the FDA for Signalmark Lung Biopsy Site Marker.

Pre-market Notification Details

Device IDK180175
510k NumberK180175
Device Name:SignalMark Lung Biopsy Site Marker
ClassificationStaple, Implantable
Applicant ViewPoint Medical, Inc. 1235 Puerta Del Sol #600 San Clemente,  CA  92673
ContactThomas Kane
CorrespondentThomas Kane
ViewPoint Medical, Inc. 1235 Puerta Del Sol #600 San Clemente,  CA  92673
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-22
Decision Date2018-12-07
Summary:summary

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