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510(k) K923872

BONE MARROW BIOPSY SYSTEM by The Straumann Co. — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1992
Date Received
August 3, 1992
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 The Straumann Co.

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  • K040646 — STRAUMANN GRANULES (May 3, 2004)
  • K040469 — THE STRAUMANN ORTHO IMPLANT SYSTEM (April 30, 2004)
  • K993862 — MODUS SAGITTAL SPLIT PLATE (December 29, 1999)
  • K962023 — PLASTIC PROTECTION HEALING CAPS (August 15, 1996)
  • K960634 — TITANIUM HEALING CAPS (June 18, 1996)
  • K955281 — ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES (March 15, 1996)
  • K955369 — MEMFIX (January 23, 1996)
  • K941393 — ITI ANGLED ABUTMENT (June 14, 1995)
  • K943720 — ITI TRANSVERSAL SCREWING SYSTEM (March 24, 1995)

Other clearances for product code GDM

  • K071732 — MARROWMINER (September 24, 2007)
  • K971114 — BIOACCESS MARROW HARVEST SYSTEM (June 3, 1997)
  • 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)
  • K915572 — BECTON DICKINSON MODIFIED MENGHINI NEEDLE (February 3, 1992)
  • K904667 — NA NEEDLES (December 12, 1990)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)