CENTRICON CONCENTRATOR

Clinical Sample Concentrator

AMICON, INC.

The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Centricon Concentrator.

Pre-market Notification Details

Device IDK893733
510k NumberK893733
Device Name:CENTRICON CONCENTRATOR
ClassificationClinical Sample Concentrator
Applicant AMICON, INC. 17 CHERRY HILL DR. Danvers,  MA  01923
ContactJames M Delaney
CorrespondentJames M Delaney
AMICON, INC. 17 CHERRY HILL DR. Danvers,  MA  01923
Product CodeJJH  
CFR Regulation Number862.2310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-17
Decision Date1989-07-20

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