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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 K092554
Device Name BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
Applicant
SUNLIGHT MEDICAL, INC.
12443 SAN JOSE BLVD.
SUITE 602
JACKSONVILLE,  FL  32223
Applicant Contact DUNSONG YANG
Correspondent
SUNLIGHT MEDICAL, INC.
12443 SAN JOSE BLVD.
SUITE 602
JACKSONVILLE,  FL  32223
Correspondent Contact DUNSONG YANG
Regulation Number884.6130
Classification Product Code
MQH  
Date Received08/20/2009
Decision Date 04/30/2010
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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