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510(k) K050795

IMBIBE BONE MARROW ASPIRATION NEEDLE by Orthovita, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2005
Date Received
March 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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  • K091618 — VITOMATRIX (September 27, 2010)

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