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510(k) K810697

AXISONIC II by Teknar, Inc. — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1981
Date Received
March 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

Other clearances by Teknar, Inc.

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  • K896150 — IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC (January 18, 1990)
  • K891777 — PRO-CUT BIOPSY NEEDLE (May 4, 1989)
  • K883965 — PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR (October 5, 1988)
  • K881850 — TEKNAR PERCU-SCAN (August 29, 1988)
  • K881605 — BIOPSY GUIDE (June 21, 1988)
  • K880659 — TEKNAR PROSCAN ACCESSORY PROBE (April 14, 1988)
  • K871536 — OPHTHASONIC A-SCAN/ B-SCAN (August 26, 1987)
  • K864807 — TEKNAR PROSCAN(TM) (July 10, 1987)

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  • K902171 — MINISPACE(TM) IUI CATHETER (October 5, 1990)
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  • K900316 — MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (April 16, 1990)
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