DIPLOMAX

Unit, Phacofragmentation

OPTICAL MICRO SYSTEMS, INC.

The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Diplomax.

Pre-market Notification Details

• Device ID: K946054
• 510k Number: K946054
• Device Name: DIPLOMAX
• Classification: Unit, Phacofragmentation
• Applicant: OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover, MA 01845
• Contact: Gerald A Clay
• Correspondent: Gerald A Clay; OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover, MA 01845
• Product Code: HQC
• CFR Regulation Number: 886.4670 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-12
• Decision Date: 1995-07-11