Thermoplastic Masks

Accelerator, Linear, Medical

Aktina Medical Corporation

The following data is part of a premarket notification filed by Aktina Medical Corporation with the FDA for Thermoplastic Masks.

Pre-market Notification Details

Device IDK192102
510k NumberK192102
Device Name:Thermoplastic Masks
ClassificationAccelerator, Linear, Medical
Applicant Aktina Medical Corporation 360 North Route 9W Congers,  NY  10920
ContactTony Spaccarotella
CorrespondentTony Spaccarotella
Aktina Medical Corporation 360 North Route 9W Congers,  NY  10920
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-05
Decision Date2019-09-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B365408011 K192102 000
B365407321 K192102 000
B365407231 K192102 000
B365407221 K192102 000
B365407411 K192102 000

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