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510(k) Clearances
/ K844597
510(k) K844597
MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT by
Xanmed Corp.
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1985
Date Received
November 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances by Xanmed Corp.
K864623
— OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT (January 14, 1987)
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)
K843641
— CATHETER INTRODUCER SYSTEM (October 23, 1984)
K843642
— SUBCLAVIAN LEAD INTRODUCER SYS (October 23, 1984)