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510(k) Data Aggregation
K Number
K010704Device Name
DORNIR LC-1 CPAP SYSTEM
Manufacturer
Date Cleared
2001-04-18
(40 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
PRYM MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000888Device Name
SANSIBAR CPAP SYSTEM
Manufacturer
Date Cleared
2000-08-15
(148 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
PRYM MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
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