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510(k) K813595

PARKE-DAVIS AEGIS ABOSRBENT SPONGES by Deseret Medical, Inc. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1982
Date Received
December 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

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  • K904122 — INSYTE-A ARTERIAL CATHETERIZATION UNIT (October 4, 1990)
  • K900116 — DESERET OPTIMA INTRAVASCULAR CATHETER (June 18, 1990)
  • K895735 — DESERET MULTILUMEN SUBCLAVIAN CATHETER (May 18, 1990)
  • K895734 — DESERET INTRAVASCULAR CATHETER (April 9, 1990)
  • K894033 — DISPOSABLE CATHETER PRESSURE TRANSDUCER (October 17, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K882797 — LUER-LOK MULTIFLO ADAPTER (July 18, 1988)

Other clearances for product code GDY

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  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953057 — CYLINDRICAL SPONGE (September 14, 1995)