THE ULTIMATE

Knife, Ophthalmic

MYOCURE, INC.

The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for The Ultimate.

Pre-market Notification Details

• Device ID: K863665
• 510k Number: K863665
• Device Name: THE ULTIMATE
• Classification: Knife, Ophthalmic
• Applicant: MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201
• Contact: Alexa C Jensen
• Correspondent: Alexa C Jensen; MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201
• Product Code: HNN
• CFR Regulation Number: 886.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-09-18
• Decision Date: 1986-09-25