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510(k) K980247

GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM by Gynex Corp. — Product Code HDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1998
Date Received
January 23, 1998
Clearance Type
Traditional
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 Gynex Corp.

  • K061306 — CO-1000 COLPOSCOPE, MULTIPLE (August 7, 2006)
  • K982739 — GYNEX ELECTRODES (March 12, 1999)
  • K980238 — GYNEX EXTENDED REACH NEEDLE (August 21, 1998)
  • K980237 — GYNEX ENDOSPECULUM (April 8, 1998)

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