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510(k) K070287

PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 by Photonic Optische Gerate GmbH & Cokg — Product Code EBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2007
Date Received
January 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical Headlight
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

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  • K842515 — SURGICAL HEADLIGHT (August 2, 1984)
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  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K790807 — METALIT (August 3, 1979)
  • K790806 — PORCELIT (August 3, 1979)