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510(k) K880905

MAMMOGRAPHY MOVING GRID BUCKY by Custom Medical Products, Ltd. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1988
Date Received
March 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Custom Medical Products, Ltd.

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  • K931456 — SURGICAL DRAPE AND GOWN TRAY (July 8, 1994)
  • K931455 — HEAD SHEET (May 5, 1994)
  • K931418 — SURGICAL DRAPE (May 5, 1994)
  • K930815 — ABDOMINAL / THORACIC PATIENT DRAPE (May 5, 1994)
  • K931844 — CUSTOM PROCEDURE MEDICAL TRAY OR KIT (January 25, 1994)
  • K926519 — SURGICAL GOWN (August 12, 1993)
  • K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)
  • K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)

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