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510(k) K880198

GEMINI SURGICAL LIGHT by American Sterilizer Co. — Product Code FSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1988
Date Received
January 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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  • K930493 — QUANTUM 3080 SURGICAL TABLE (June 22, 1993)
  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K896674 — AMSCO QUANTUM LIGHT (January 3, 1990)
  • K895164 — EAGLE DS (November 17, 1989)
  • K882660 — GENERAL SURGICAL TABLE AND ACCESSORIES (July 25, 1988)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)
  • K844479 — CHEMSPOR (November 25, 1985)

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