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510(k) K895551

ROCKET BONE MARROW NEEDLE by A & A Medical, Inc. — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
September 13, 1989
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 A & A Medical, Inc.

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  • K003949 — TACKER, MODEL R65-933 (July 25, 2001)
  • K011512 — MMODIFICATION TO LAMINARIA (July 9, 2001)
  • K010510 — BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 (May 16, 2001)
  • K010789 — CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, (April 27, 2001)
  • K010056 — UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 (February 1, 2001)
  • K000027 — INSUFFLATION NEEDLE, MODEL R65-933 (April 3, 2000)
  • K994256 — SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (February 3, 2000)
  • K974038 — THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPR (May 11, 1998)

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)
  • K923872 — BONE MARROW BIOPSY SYSTEM (December 15, 1992)
  • 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)