SMA 26 TRANSDUCER

Transducer, Ultrasonic, Diagnostic

PAREXEL INTL. CORP.

The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Sma 26 Transducer.

Pre-market Notification Details

Device IDK904902
510k NumberK904902
Device Name:SMA 26 TRANSDUCER
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge,  MS  02140
ContactBarry Sall
CorrespondentBarry Sall
PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge,  MS  02140
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-30
Decision Date1991-03-26

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