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510(k) K853948

MINNESOTA SCIENTIFIC, INC. OMNI-BEAM by Minnesota Scientific, Inc. — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
September 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Minnesota Scientific, Inc.

  • K872919 — OMNI-TRACT CORRAL RETRACTOR (August 11, 1987)
  • K853947 — OMNI-TRACT CHEST WALL & LUNA RETRACTOR (October 16, 1985)
  • K842762 — OMNI-TRACT SURGICAL RETRACTOR SYS (August 17, 1984)
  • K810282 — OPERATING TABLE ACCESSORY CLAMP (February 26, 1981)

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