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

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• Device ID: BK180287
• 510k Number: BK180287
• Device Name: Fibrin Sealant Preparation Device
• Classification: Fibrin Sealant Preparation Device
• Applicant: ETHICON Inc. route 22 West p.o. Box 151 Somerville, NJ 08876 US
• Product Code: MZM
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-19
• Decision Date: 2019-04-10