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510(k) K831829

KARICKHOFF FLYING CORPUSCLE VIEWER by Surgidev Corp. — Product Code HIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1983
Date Received
June 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Maxwell Spot, Ac-Powered
Device Class
Class I
Regulation Number
886.1435
Review Panel
OP
Submission Type

Other clearances by Surgidev Corp.

  • K850729 — ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000 (April 9, 1985)
  • K831975 — LEADING EDGE OPHTHALMIC KNIFE (August 31, 1983)
  • K830008 — KARICKHOFF KERATOSCOPE (January 26, 1983)

Other clearances for product code HIX

  • K801554 — STERILE CAST PADDING (August 4, 1980)