BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY

System, X-ray, Mammographic

BENNETT X-RAY CORP.

The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Bennett X-ray Profile Positioning Paddle For Mammography.

Pre-market Notification Details

Device IDK945962
510k NumberK945962
Device Name:BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY
ClassificationSystem, X-ray, Mammographic
Applicant BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague,  NY  11726
ContactRobert P Coe
CorrespondentRobert P Coe
BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague,  NY  11726
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-07
Decision Date1995-04-03

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