MARK3

Material, Impression

CAVEX HOLLAND B.V

The following data is part of a premarket notification filed by Cavex Holland B.v with the FDA for Mark3.

Pre-market Notification Details

• Device ID: K141092
• 510k Number: K141092
• Device Name: MARK3
• Classification: Material, Impression
• Applicant: CAVEX HOLLAND B.V P.O. BOX 852 Haarlem, NL 2031 Wh
• Contact: R, Woortman
• Correspondent: R, Woortman; CAVEX HOLLAND B.V P.O. BOX 852 Haarlem, NL 2031 Wh
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-04-28
• Decision Date: 2014-12-04
• Summary: summary