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510(k) Data Aggregation
K Number
K102165Device Name
STERILE SALINE SOLUTION
Manufacturer
CACHET PHARMACEUTICALS PVT. LTD.
Date Cleared
2011-01-19
(170 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
CACHET PHARMACEUTICALS PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.
Device Description
Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate, Boric Acid and Nitrogen as Propellant. The solution is packaged in lacquered aluminum spray containers with caps. Each container is sealed with a tamper evident hologram seal at the junction of the container and the cap.
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K Number
K093367Device Name
STERILE SALINE SOLUTION
Manufacturer
CACHET PHARMACEUTICALS PVT. LTD.
Date Cleared
2010-09-10
(316 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
CACHET PHARMACEUTICALS PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Saline Solution is indicated for rinsing & wetting of soft (hydrophilic) contact lenses.
Device Description
Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate and Boric Acid. The solution is packaged in plastic sterile single use twist open pods, reusable bottles with dropper tips and caps. Each bottle is closed with tamper resistant cap with a breakable ring, which must be broken in order to open the bottle.
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