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FDA 510(k), K101557, GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
FDA 510(k), K101557, GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
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510(K) Number: K101557
Device Name: GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
Manufacturer: ETEX CORP.
Device Classification Name: filler, bone void, calcium compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 06/04/2010
Decision Date: 07/01/2010
Regulation Medical Specialty: Orthopedic
Device Name: GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
Manufacturer: ETEX CORP.
Device Classification Name: filler, bone void, calcium compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 06/04/2010
Decision Date: 07/01/2010
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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