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510(k) K830474

IV STAND by Teknar, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
February 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Teknar, Inc.

  • K903666 — OPHTHASONIC A/P III (November 19, 1990)
  • K896038 — B-SCAN 10 MHZ PROBE (April 23, 1990)
  • 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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