FDA 510(k) Application Details - K031972

Device Classification Name Arthroscope

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510(K) Number K031972
Device Name Arthroscope
Applicant ASAP ENDOSCOPIC PRODUCTS GMBH
KATHARINENSTR. 5
LUEBECK 23554 DE
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Contact MARTINA GUNDEROTH
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 06/26/2003
Decision Date 09/15/2003
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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