Tangible Boost

Hydrophilic Re-coating Solution

Tangible Science, Inc.

The following data is part of a De Novo classification by Tangible Science, Inc. with the FDA for Tangible Boost.

Pre-market Notification Details

• DeNovo ID: DEN200002
• Device Name: Tangible Boost
• Classification: Hydrophilic Re-coating Solution
• Applicant: Tangible Science, Inc. 740 Broadway Redwood City, CA 94063
• Contact: Kelly Mabry
• Product Code: QMM
• CFR Regulation Number: 886.5919 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Ophthalmic
• Classification Advisory: Ophthalmic
• Type: Direct
• Date Received: 2020-01-13
• Decision Date: 2020-09-24
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B673FG6	DEN200002	000