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510(k) K863326

BONE MARROW TRAY by Packaging Technologies, Inc. — Product Code GAA

K863326 is an FDA 510(k) premarket notification submitted by Packaging Technologies, Inc. for the device "BONE MARROW TRAY". The FDA issued a decision of Substantially Equivalent on September 16, 1986. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Packaging Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1986
Date Received
August 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Packaging Technologies, Inc.

  • K881756 — STERILE SURGEONS GLOVES (June 1, 1988)
  • K861041 — ENHANCE (May 30, 1986)
  • K850544 — SHAVE PREP TRAY (March 12, 1985)
  • K850438 — RENAL BIOPSY TRAY (February 26, 1985)
  • K844613 — GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (January 10, 1985)
  • K844611 — SINGLE BASIN SET (December 19, 1984)
  • K844614 — IV START KIT (December 19, 1984)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K834074 — PERCUTANEOUS SHEATH INTRODUCER TRAY (March 19, 1984)
  • K834073 — CENTRAL VEIN CATHERIZATION TRAY CC-20 (February 28, 1984)

Other clearances for product code GAA

  • K223625 — CapnoSpot™ Pneumothorax Decompression Indicator (March 28, 2023)
  • K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (June 15, 2011)
  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K974741 — MANAN ACCURA NEEDLE (January 8, 1998)
  • K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (September 11, 1996)
  • K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW (July 19, 1996)
  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
  • K940024 — MANAN GENERAL PURPOSE INTRODUCER NEEDLE (February 25, 1994)

FDA data resources