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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filler, bone void, calcium compound
510(k) Number K193168
Device Name Agilon Moldable
Applicant
Biogennix, LLC.
1641 McGaw Ave
Irvine,  CA  92614
Applicant Contact Timothy Bumbalough
Correspondent
Paladin Medical, Inc
PO Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/15/2019
Decision Date 02/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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