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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 K132805
Device Name BG MORSELS
Applicant
Prosidyan, Inc.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
Prosidyan, Inc.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/06/2013
Decision Date 03/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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