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510(k) K954151

BIOACCESS BONE BIOPSY SYSTEM by Bioaccess, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
September 5, 1995
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

Other clearances by Bioaccess, Inc.

  • K971114 — BIOACCESS MARROW HARVEST SYSTEM (June 3, 1997)
  • K953064 — BIOACCESS MARROW HARVEST SYSTEM (August 7, 1995)

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