FLUTTER D

Percussor, Powered-electric

BRADSTREET CLINICAL RESEARCH ASSOC., INC.

The following data is part of a premarket notification filed by Bradstreet Clinical Research Assoc., Inc. with the FDA for Flutter D.

Pre-market Notification Details

Device IDK972859
510k NumberK972859
Device Name:FLUTTER D
ClassificationPercussor, Powered-electric
Applicant BRADSTREET CLINICAL RESEARCH ASSOC., INC. 1588 ROUTE 130 NORTH SUITE C-2 North Brunswick,  NJ  08902
ContactPatricia W Bradstreet
CorrespondentPatricia W Bradstreet
BRADSTREET CLINICAL RESEARCH ASSOC., INC. 1588 ROUTE 130 NORTH SUITE C-2 North Brunswick,  NJ  08902
Product CodeBYI  
CFR Regulation Number868.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-04
Decision Date1998-06-05
Summary:summary

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