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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
Applicant
PLANER PLC
15696 OAKSTAND ROAD
POWAY,  CA  92064 -3389
Applicant Contact ERIC GRUFF
Correspondent
PLANER PLC
15696 OAKSTAND ROAD
POWAY,  CA  92064 -3389
Correspondent 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
Recalls CDRH Recalls
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