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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 K990941
Device Name NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
Applicant
HUMAGEN FERTILITY DIAGNOSTICS, INC.
2400 HUNTER'S WAY
CHARLOTTESVILLE,  VA  22911
Applicant Contact CINDY SHOWALTER
Correspondent
HUMAGEN FERTILITY DIAGNOSTICS, INC.
2400 HUNTER'S WAY
CHARLOTTESVILLE,  VA  22911
Correspondent Contact CINDY SHOWALTER
Regulation Number884.6160
Classification Product Code
MQK  
Date Received03/22/1999
Decision Date 07/14/1999
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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