FDA 510(k) Application Details - K994231

Device Classification Name Endoscopic Central Control Unit

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510(K) Number K994231
Device Name Endoscopic Central Control Unit
Applicant SIEMENS MEDICAL CORP.
186 WOOD AVE. SOUTH
ISELIN, NJ 08830 US
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Contact MALGORZATA STANEK
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Regulation Number 876.1500

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Classification Product Code ODA
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Date Received 12/16/1999
Decision Date 08/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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