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510(k) K083066

CHROMOPHARE E 778 AND E 558 by Berchtold Holding GmbH — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2008
Date Received
October 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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  • K944855 — CHROMOPHARE (October 19, 1994)
  • K942319 — HIRSCH BIPOLAR COAGULATION FORCEPS AND ADAPTOR CABLES (June 8, 1994)

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