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510(k) K032585

TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM by Ron-Tech Medical , Ltd. — Product Code HDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2004
Date Received
August 21, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tenaculum, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Ron-Tech Medical , Ltd.

  • K992071 — TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (August 27, 1999)

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  • K082349 — JARIT HULKA UTERINE TENACULUM FORCEPS (November 21, 2008)
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  • K062563 — FEMTEN CERVICAL TENACULUM (May 18, 2007)
  • K060573 — BURBANK TENACULUM (April 21, 2006)
  • K030078 — BURBANK TENACULUM, MODEL 09-0011-01 (January 24, 2003)
  • K001818 — UTERINE TENACLUM HOOK (August 30, 2000)
  • K992071 — TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (August 27, 1999)