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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 K022643
Device Name BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
Applicant
SWEMED LAB INTERNATIONAL AB
555 13TH ST. N.W.
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
SWEMED LAB INTERNATIONAL AB
555 13TH ST. N.W.
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number884.6130
Classification Product Code
MQH  
Date Received08/08/2002
Decision Date 11/05/2002
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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