INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M

Microtools, Assisted Reproduction (pipettes)

HUMAGEN FERTILITY DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Humagen Fertility Diagnostics, Inc. with the FDA for Intracytoplasmic Sperm Injection Micropipets (icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M.

Pre-market Notification Details

Device IDK990847
510k NumberK990847
Device Name:INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M
ClassificationMicrotools, Assisted Reproduction (pipettes)
Applicant HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville,  VA  22911
ContactCindy Showalter
CorrespondentCindy Showalter
HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville,  VA  22911
Product CodeMQH  
CFR Regulation Number884.6130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-15
Decision Date1999-07-14
Summary:summary

NIH GUDID Devices

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