HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

Lenses, Soft Contact, Daily Wear

POLY VUE TECHNOLGIES, INC.

The following data is part of a premarket notification filed by Poly Vue Technolgies, Inc. with the FDA for Hd/hdt, (polymacon) Soft Contact Lens For Daily Wear (clear And Tinted, Fully Cast-molded Lens).

Pre-market Notification Details

• Device ID: K020608
• 510k Number: K020608
• Device Name: HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
• Classification: Lenses, Soft Contact, Daily Wear
• Applicant: POLY VUE TECHNOLGIES, INC. 623 GLACIER DR. Grand Junction, CO 81503
• Contact: Deanna Werber
• Correspondent: Deanna Werber; POLY VUE TECHNOLGIES, INC. 623 GLACIER DR. Grand Junction, CO 81503
• Product Code: LPL
• CFR Regulation Number: 886.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-02-25
• Decision Date: 2002-05-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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