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510(k) Data Aggregation
K Number
K013715Device Name
RE-USABLE STERILIZATION POUCH / BAG
Manufacturer
Date Cleared
2002-04-01
(144 days)
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
QUALITY PRODUCTS OF MONTANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a re-usable sterilization pouch designed to The device the sterilization process and allow a simple method of packaging devices to maintain sterility. Acceptable method of sterilization is moist heat sterilization where the temperature is below 137℃ (273°F). The pouch may be re-used up to 30 times in dental practices and approved for 90 days storage.
Device Description
The device is a re-usable sterilization pouch designed to The device the sterilization process and allow a simple method of packaging devices to maintain sterility.
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