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510(k) K993314

SYNTHES LIGHT GUIDE by Synthes (Usa) — Product Code FQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1999
Date Received
October 4, 1999
Clearance Type
Abbreviated
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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Other clearances for product code FQP

  • K001223 — ACULUX, MODEL AX3001, AX3002 (June 23, 2000)
  • K781581 — SURGICAL LIGHT 22 SERIES (October 17, 1978)
  • K770812 — HANDLES, LIGHT, SURGICAL, STEOILE (May 23, 1977)
  • K761018 — SURGICAL LIGHT - CHALLENGE 22 SERIES (January 26, 1977)