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510(k) Data Aggregation
K Number
K021438Device Name
INSEMINATION CATHETER, MODEL 320301
Manufacturer
LABOTECT LABOR-TECHNIK GOTTINGEN
Date Cleared
2002-07-16
(71 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Applicant Name (Manufacturer) :
LABOTECT LABOR-TECHNIK GOTTINGEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The catheter is used for intrauterine insemination.
Device Description
The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.
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K Number
K003056Device Name
OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
Manufacturer
LABOTECT LABOR-TECHNIK GOTTINGEN
Date Cleared
2000-12-13
(73 days)
Product Code
MQE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
LABOTECT LABOR-TECHNIK GOTTINGEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000950Device Name
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
Manufacturer
LABOTECT LABOR-TECHNIK GOTTINGEN
Date Cleared
2000-05-12
(50 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
LABOTECT LABOR-TECHNIK GOTTINGEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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