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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtools, Assisted Reproduction (Pipettes)
510(k) Number K990847
Device Name INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M
Applicant
Humagen Fertility Diagnostics, Inc.
2400 Hunter'S Way
Charlottesville,  VA  22911
Applicant Contact CINDY SHOWALTER
Correspondent
Humagen Fertility Diagnostics, Inc.
2400 Hunter'S Way
Charlottesville,  VA  22911
Correspondent Contact CINDY SHOWALTER
Regulation Number884.6130
Classification Product Code
MQH  
Date Received03/15/1999
Decision Date 07/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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