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Found 5 results
510(k) Data Aggregation
K Number
K030117Device Name
ENHANCE SPERM FREEZE
Manufacturer
CONCEPTION TECHNOLOGY, INC.
Date Cleared
2003-03-20
(66 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
CONCEPTION TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sperm Freeze is intended to be used as a cryopreservation medium for human sperm.
Device Description
Not Found
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K Number
K030116Device Name
ENHANCE-S PLUS H
Manufacturer
CONCEPTION TECHNOLOGY, INC.
Date Cleared
2003-02-12
(30 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
CONCEPTION TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
Device Description
Not Found
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K Number
K991322Device Name
ENHANCE-S PLUS
Manufacturer
CONCEPTION TECHNOLOGY, INC.
Date Cleared
1999-07-26
(98 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
CONCEPTION TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
Device Description
Not Found
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K Number
K991104Device Name
MICROTOOLS
Manufacturer
CONCEPTION TECHNOLOGY, INC.
Date Cleared
1999-07-19
(109 days)
Product Code
MQH
Regulation Number
884.6130Why did this record match?
Applicant Name (Manufacturer) :
CONCEPTION TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conceptions Technologies' Microtools are used in the laboratory as a microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction procedures.
Device Description
Microtools
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K Number
K973860Device Name
OVULON MONITOR
Manufacturer
CONCEPTION TECHNOLOGY, INC.
Date Cleared
1998-01-07
(90 days)
Product Code
NGE
Regulation Number
862.1485Why did this record match?
Applicant Name (Manufacturer) :
CONCEPTION TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques.
The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception.
After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.
Device Description
The Ovulon Monitor is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
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