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510(k) K761018

SURGICAL LIGHT - CHALLENGE 22 SERIES by Amsco Co. — Product Code FQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1977
Date Received
November 10, 1976
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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  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)

Other clearances for product code FQP

  • K001223 — ACULUX, MODEL AX3001, AX3002 (June 23, 2000)
  • K993314 — SYNTHES LIGHT GUIDE (December 6, 1999)
  • K781581 — SURGICAL LIGHT 22 SERIES (October 17, 1978)
  • K770812 — HANDLES, LIGHT, SURGICAL, STEOILE (May 23, 1977)