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510(k) K781581

SURGICAL LIGHT 22 SERIES by American Sterilizer Co. — Product Code FQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1978
Date Received
September 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Operating-Room
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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  • K905816 — ORTHOVISION TABLE (March 6, 1991)
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  • K895164 — EAGLE DS (November 17, 1989)
  • K882660 — GENERAL SURGICAL TABLE AND ACCESSORIES (July 25, 1988)
  • K880198 — GEMINI SURGICAL LIGHT (February 10, 1988)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)

Other clearances for product code FQP

  • K001223 — ACULUX, MODEL AX3001, AX3002 (June 23, 2000)
  • K993314 — SYNTHES LIGHT GUIDE (December 6, 1999)
  • K770812 — HANDLES, LIGHT, SURGICAL, STEOILE (May 23, 1977)
  • K761018 — SURGICAL LIGHT - CHALLENGE 22 SERIES (January 26, 1977)