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510(k) K964005

SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE by Synergetics, Inc. — Product Code MPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1997
Date Received
September 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

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  • K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 (December 20, 2007)
  • K063489 — STRYKER INTRADISCAL RF GENERATOR (May 23, 2007)
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