SURFACE COAT

Coating, Filling Material, Resin

KURARAY AMERICA, INC.

The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Surface Coat.

Pre-market Notification Details

• Device ID: K063228
• 510k Number: K063228
• Device Name: SURFACE COAT
• Classification: Coating, Filling Material, Resin
• Applicant: KURARAY AMERICA, INC. 600 LEXINGTON AVE. 26TH FLOOR New York, NY 10022
• Contact: Koji Nishida
• Correspondent: Koji Nishida; KURARAY AMERICA, INC. 600 LEXINGTON AVE. 26TH FLOOR New York, NY 10022
• Product Code: EBD
• CFR Regulation Number: 872.3310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-10-25
• Decision Date: 2006-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EKUR000263KA1	K063228	000