FDA 510(k) Application Details - K092977

Device Classification Name Arthroscope

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510(K) Number K092977
Device Name Arthroscope
Applicant EFS EBERLE FEINWERKTECHNISCHE SYSTEME
731-733 SHOTGUN ROAD
FT. LAUDERDALE, FL 33326 US
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Contact GERALD GOIGITZER
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/25/2009
Decision Date 09/29/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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