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510(k) K021017

LEESPEC DISPOSABLE VAGINAL SPECULUM by Itl Corporation Pty, Ltd. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2002
Date Received
March 29, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Itl Corporation Pty, Ltd.

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  • K021941 — SAMPLOK LUER KIT (July 2, 2002)
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  • K991404 — PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) (May 14, 1999)

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  • K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM (August 6, 2013)
  • K120743 — SPECULUM, VAGINAL, NONMETAL (March 23, 2012)
  • K110766 — KOLPLUX SYSTEM (September 15, 2011)
  • K092870 — NON-STERILE DISPOSABLE VAGINAL SPECULUM (February 16, 2010)
  • K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (September 9, 2009)
  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
  • K072762 — DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (January 22, 2008)