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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
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 (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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