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510(k) K973958

GENERAL PURPOSE ATL NEEDLE GUIDE KIT by Protek Medical Products, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1998
Date Received
October 16, 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.

  • 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)
  • K971115 — GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE (June 13, 1997)

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