FLEXLENS

Lenses, Soft Contact, Daily Wear

FLEXLENS, INC.

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

Pre-market Notification Details

• Device ID: K961943
• 510k Number: K961943
• Device Name: FLEXLENS
• Classification: Lenses, Soft Contact, Daily Wear
• Applicant: FLEXLENS, INC. S. EAST REGULATORY ASSO., INC. 235 NORTH TALBOT COURT Roswell, GA 30076 -2480
• Contact: Wally Stirling
• Correspondent: Wally Stirling; FLEXLENS, INC. S. EAST REGULATORY ASSO., INC. 235 NORTH TALBOT COURT Roswell, GA 30076 -2480
• Product Code: LPL
• CFR Regulation Number: 886.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-20
• Decision Date: 1996-10-01
• Summary: summary