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510(k) K971114

BIOACCESS MARROW HARVEST SYSTEM by Bioaccess, Inc. — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
March 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Bioaccess, Inc.

  • K954151 — BIOACCESS BONE BIOPSY SYSTEM (September 15, 1995)
  • K953064 — BIOACCESS MARROW HARVEST SYSTEM (August 7, 1995)

Other clearances for product code GDM

  • K071732 — MARROWMINER (September 24, 2007)
  • K953082 — ILIAC CREST BONE MARROW ASPIRATION NEEDLE (September 22, 1995)
  • K953064 — BIOACCESS MARROW HARVEST SYSTEM (August 7, 1995)
  • K936207 — ENDO-NEEDLE INSTRUMENT (June 16, 1994)
  • K930160 — ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE (July 6, 1993)
  • K923872 — BONE MARROW BIOPSY SYSTEM (December 15, 1992)
  • K915572 — BECTON DICKINSON MODIFIED MENGHINI NEEDLE (February 3, 1992)
  • K904667 — NA NEEDLES (December 12, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)