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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessory, assisted reproduction
510(k) Number K030525
Device Name CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
Original Applicant
MID-ATLANTIC DIAGNOSTICS, INC.
438 north elmwood rd.
marlton,  NJ  08053
Original Contact susan j bush
Regulation Number884.6120
Classification Product Code
MQG  
Date Received02/19/2003
Decision Date 08/27/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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