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510(k) Data Aggregation
K Number
K024290Device Name
PROMOTOR FINAL RINSE SPERM WASH MEDIUM
Manufacturer
Date Cleared
2003-03-03
(70 days)
Product Code
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
CERES FERTILITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Promotor Final Rinse Sperm Wash is to be used as a sperm processing medium in washing procedures and for transport of sperm during reproductive technology procedures.
Device Description
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K Number
K023106Device Name
PROMOTOR
Manufacturer
Date Cleared
2002-11-05
(48 days)
Product Code
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
CERES FERTILITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
Device Description
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