MENICON Z

Lens, Contact (other Material) - Daily

MENICON U.S.A., INC.

The following data is part of a premarket notification filed by Menicon U.s.a., Inc. with the FDA for Menicon Z.

Pre-market Notification Details

• Device ID: K000133
• 510k Number: K000133
• Device Name: MENICON Z
• Classification: Lens, Contact (other Material) - Daily
• Applicant: MENICON U.S.A., INC. 269 A BALLARDVALE ST. Wilmington, MA 01887
• Contact: Beverly D Venuti
• Correspondent: Beverly D Venuti; MENICON U.S.A., INC. 269 A BALLARDVALE ST. Wilmington, MA 01887
• Product Code: HQD
• CFR Regulation Number: 886.5916 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-01-18
• Decision Date: 2000-05-19