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510(k) K892070

GENERAL IVT NEEDLE GUIDE KIT, STERILE by Amedic USA — Product Code HGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
March 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type

Other clearances by Amedic USA

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  • K892069 — EXTENDED COVERS, STERILE (August 8, 1989)
  • K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE (August 4, 1989)
  • K871467 — BIOPSY NEEDLE GUIDE KIT, STERILE (August 21, 1987)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K871609 — ULTRASOUND TRANSDUCER SHEATHS, STERILE (July 15, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K864219 — TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE (March 27, 1987)

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