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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name labware, assisted reproduction
510(k) Number K991251
Device Name FALCON IVF ONE WELL DISH
Applicant
BECTON DICKINSON LABWARE
1 BECTON DR.
FRANKLIN LAKES,  NJ  07465 -1886
Applicant Contact DAVID BALL
Correspondent
BECTON DICKINSON LABWARE
1 BECTON DR.
FRANKLIN LAKES,  NJ  07465 -1886
Correspondent Contact DAVID BALL
Regulation Number884.6160
Classification Product Code
MQK  
Date Received04/13/1999
Decision Date 05/05/1999
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
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