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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 K012811
Device Name BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
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 Received08/22/2001
Decision Date 02/11/2002
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
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