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510(k) K090773

CFI ULTRASOUND PROBE DRAPE by Contour Fabricators, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2009
Date Received
March 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Contour Fabricators, Inc.

  • K970900 — INSTRUMENT HOLDER (May 22, 1997)
  • K971040 — CABLE HOLDER, SUCTION TUBE HOLDER (April 16, 1997)
  • K970185 — STERILE DISPOSABLE EQUIPMENT MAGNET COVER (April 10, 1997)
  • K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER (January 30, 1997)
  • K963453 — CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) (November 15, 1996)
  • K820692 — BANDBAG, WRAP, STERILE (May 3, 1982)
  • K782155 — GENERAL EQUIPMENT COVER (January 17, 1979)

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