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510(k) K971115

GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE by Protek Medical Products, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1997
Date Received
March 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Protek Medical Products, Inc.

  • K973958 — GENERAL PURPOSE ATL NEEDLE GUIDE KIT (January 22, 1998)
  • K973622 — TRANSDUCER POSITIONER (November 26, 1997)
  • K970893 — ULTRASOUND TRANSDUCER DRAPE (October 20, 1997)
  • K970889 — ULTRASOUND TRANSDUCER DRAPE (October 20, 1997)
  • K973362 — NEEDLE GUIDE/GRID (October 1, 1997)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K970891 — DRAPE, SURGICAL-LATEX (August 22, 1997)
  • K971722 — TRANS VAGINAL NEEDLE GUIDE (July 10, 1997)

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