Search Results
Found 1 results
510(k) Data Aggregation
K Number
K193441Device Name
Aqua Naina Sterile Saline Solution
Manufacturer
Chemtex USA, Inc.
Date Cleared
2020-05-26
(167 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
Chemtex USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.
Device Description
Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear colorless aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.
Ask a Question
Page 1 of 1