ISIGHT

Lenses, Soft Contact, Daily Wear

C & E GP SPECIALISTS, INC.

The following data is part of a premarket notification filed by C & E Gp Specialists, Inc. with the FDA for Isight.

Pre-market Notification Details

• Device ID: K121519
• 510k Number: K121519
• Device Name: ISIGHT
• Classification: Lenses, Soft Contact, Daily Wear
• Applicant: C & E GP SPECIALISTS, INC. 2214 SANFORD DR Grand Junction, CO 81505
• Contact: Martin Dalsing
• Correspondent: Martin Dalsing; C & E GP SPECIALISTS, INC. 2214 SANFORD DR Grand Junction, CO 81505
• Product Code: LPL
• CFR Regulation Number: 886.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-22
• Decision Date: 2012-09-18
• Summary: summary