ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.

Biopsy Needle

ACUSON CORP.

The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson Transrectal Needle Guide For Intra. Appli..

Pre-market Notification Details

Device IDK882549
510k NumberK882549
Device Name:ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
ClassificationBiopsy Needle
Applicant ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
ContactRobert J Gallagher
CorrespondentRobert J Gallagher
ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-20
Decision Date1988-07-21

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