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510(k) K000777

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2000
Date Received
March 9, 2000
Clearance Type
Traditional
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)
  • K021941 — SAMPLOK LUER KIT (July 2, 2002)
  • K021017 — LEESPEC DISPOSABLE VAGINAL SPECULUM (June 19, 2002)
  • K991404 — PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) (May 14, 1999)

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