BEAM BLOCK TRAYS

Accelerator, Linear, Medical

AKTINA MEDICAL PHYSICS CORP.

The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Beam Block Trays.

Pre-market Notification Details

Device IDK964840
510k NumberK964840
Device Name:BEAM BLOCK TRAYS
ClassificationAccelerator, Linear, Medical
Applicant AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers,  NY  10920
ContactJoan Zacharopoulos
CorrespondentJoan Zacharopoulos
AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers,  NY  10920
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-29
Decision Date1997-02-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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B365113000 K964840 000

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