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510(k) K791156

AMIPAQUE MYELOGRAM TRAY by Pharmaseal Div., Baxter Healthcare Corp. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
June 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Pharmaseal Div., Baxter Healthcare Corp.

  • K792369 — HYPERALIMENTATION DRESSING TRAY (December 10, 1979)
  • K792141 — CONTINUOUS FLUSH DEVICE (December 5, 1979)
  • K792019 — PHADECODE XA INHIBITOR ASSAY (November 5, 1979)
  • K791773 — VENTILATOR TUBE WITH FILTER (October 22, 1979)
  • K790896 — TWO-WAY ANESTHESIA FILTER (June 5, 1979)
  • K790409 — LOW DEAD SPACE INSULIN SYRINGE (April 24, 1979)
  • K782069 — TRAY, AUXILLARY BLOCK (January 4, 1979)
  • K781797 — PREP TRAY, PREOPERATIVE SKIN (November 8, 1978)
  • K781680 — MONITORING, PRESSURE KIT (October 6, 1978)
  • K780887 — IMPROVED DISPOSABLE HYPODERMIC NEEDLE (June 22, 1978)

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