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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
Applicant
MID-ATLANTIC DIAGNOSTICS, INC.
438 NORTH ELMWOOD RD.
MARLTON,  NJ  08053
Applicant Contact SUSAN J BUSH
Correspondent
MID-ATLANTIC DIAGNOSTICS, INC.
438 NORTH ELMWOOD RD.
MARLTON,  NJ  08053
Correspondent Contact SUSAN J BUSH
Regulation Number884.6120
Classification Product Code
MQG  
Date Received02/19/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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