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510(k) K021941

SAMPLOK LUER KIT by Itl Corporation Pty, Ltd. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
June 13, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Itl Corporation Pty, Ltd.

  • K153472 — Quiver Laparoscopic Extendable (June 23, 2016)
  • K021017 — LEESPEC DISPOSABLE VAGINAL SPECULUM (June 19, 2002)
  • K000777 — SAMPLOK (April 11, 2000)
  • K991404 — PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) (May 14, 1999)

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