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510(k) K110628

SIMPLEABI by Newman Medical — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2011
Date Received
March 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

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