FDA 510(k) Application Details - K060172

Device Classification Name Arthroscope

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510(K) Number K060172
Device Name Arthroscope
Applicant REMA MEDIZINTECHNIK GMBH.
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 01/23/2006
Decision Date 05/31/2006
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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