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510(k) Data Aggregation
K Number
K981905Device Name
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291
Manufacturer
Date Cleared
1998-08-18
(78 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
ACU-PAK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ACU-PAK Sterile Saline Solution 0.9% / Sterile Water are used in health care facilities for the irrigation of general medical devices. It is used as a lubricant for suction catheters.
Device Description
ACU-PAK Sterile Saline Solution 0.9% and Sterile Water are used for the irrigation of medical devices. The device consists of 100ml of Saline Solution at a concentration of 0.9% or Water contained within a 100cc polyethylene wide mouthed bottle. The closure is a 38/400 white polypropylene cap fitted with an F 217 liner. A printed tamper-evident band is placed over the top of the bottle. Each bottle contains a product label displaying a lot code and expiration date.
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