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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 K121566
Model BT37
Device Name PLANER BT37 INCUBATOR
Original Applicant
PLANER PLC
15696 oakstand road
poway,  CA  92064 3389
Original Contact eric gruff
Regulation Number884.6120
Classification Product Code
MQG  
Date Received05/29/2012
Decision Date 11/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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