Fibrin Sealant Preparation Device

Fibrin Sealant Preparation Device

ETHICON Inc.

The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Fibrin Sealant Preparation Device.

Pre-market Notification Details

Device IDBK190324
510k NumberBK190324
Device Name:Fibrin Sealant Preparation Device
ClassificationFibrin Sealant Preparation Device
Applicant ETHICON Inc. route 22 West p.o. Box 151 Somerville,  NJ  08876 US
Product CodeMZM  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-28
Decision Date2019-06-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30705031462728 BK190324 0
20705031462578 BK190324 0

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