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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, cranial
510(k) Number K133397
Device Name P-POD
Applicant
P-POD
7828 HICKORY FLAT HWY.
SUITE 120
WOODSTOCK,  GA  30188
Applicant Contact LINDA BRADDON
Correspondent
P-POD
7828 HICKORY FLAT HWY.
SUITE 120
WOODSTOCK,  GA  30188
Correspondent Contact LINDA BRADDON
Regulation Number882.5970
Classification Product Code
MVA  
Date Received11/06/2013
Decision Date 04/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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