FIBRINOGEN UPTAKE SYS -VARIOUS MODELS

Snare, Ear

CANBERRA INDUSTRIES, INC.

The following data is part of a premarket notification filed by Canberra Industries, Inc. with the FDA for Fibrinogen Uptake Sys -various Models.

Pre-market Notification Details

Device IDK834168
510k NumberK834168
Device Name:FIBRINOGEN UPTAKE SYS -VARIOUS MODELS
ClassificationSnare, Ear
Applicant CANBERRA INDUSTRIES, INC. 45 GRACEY AVENUE Meriden ,  CT  06450 -
ContactRon Simmons
CorrespondentRon Simmons
CANBERRA INDUSTRIES, INC. 45 GRACEY AVENUE Meriden ,  CT  06450 -
Product CodeJZD  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-04
Decision Date1983-12-29

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