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510(k) K864623

OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT by Xanmed Corp. — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1987
Date Received
November 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Xanmed Corp.

  • K844595 — ORTHOPEDIC CUSTOM SURGICAL KIT (August 21, 1985)
  • K844596 — EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT (August 1, 1985)
  • K844593 — CARDIOVASCULAR CUSTOM SURGICAL KIT (June 21, 1985)
  • K844594 — NEURO CUSTOM SURGICAL KIT (June 13, 1985)
  • K851906 — SURGICAL EYE PACK (May 21, 1985)
  • K844597 — MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT (April 8, 1985)
  • K843641 — CATHETER INTRODUCER SYSTEM (October 23, 1984)
  • K843642 — SUBCLAVIAN LEAD INTRODUCER SYS (October 23, 1984)

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