FDA 510(k) Application Details - K960486

Device Classification Name Withdrawal/Infusion Pump

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510(K) Number K960486
Device Name Withdrawal/Infusion Pump
Applicant KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact RENATE A MACLAREN
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Regulation Number 870.1800

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Classification Product Code DQI
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Date Received 02/02/1996
Decision Date 10/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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