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510(k) K834074

PERCUTANEOUS SHEATH INTRODUCER TRAY by Packaging Technologies, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1984
Date Received
November 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Packaging Technologies, Inc.

  • K881756 — STERILE SURGEONS GLOVES (June 1, 1988)
  • K863326 — BONE MARROW TRAY (September 16, 1986)
  • 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)
  • K844614 — IV START KIT (December 19, 1984)
  • K844611 — SINGLE BASIN SET (December 19, 1984)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K834073 — CENTRAL VEIN CATHERIZATION TRAY CC-20 (February 28, 1984)

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