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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 K133742
Device Name XQ-1 INCUBATOR
Applicant
AT MEDICAL UAB
DRAUGYSTES G.19
KAUNAS,  LT 51230
Applicant Contact THOMAS PEDERSEN
Correspondent
AT MEDICAL UAB
DRAUGYSTES G.19
KAUNAS,  LT 51230
Correspondent Contact THOMAS PEDERSEN
Regulation Number884.6120
Classification Product Code
MQG  
Date Received12/09/2013
Decision Date 04/23/2014
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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