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510(k) K970893

ULTRASOUND TRANSDUCER DRAPE by Protek Medical Products, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
March 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
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)
  • 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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