FDA 510(k) Application Details - K022248

Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems

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510(K) Number K022248
Device Name Monitor, Electric For Gravity Flow Infusion Systems
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact MICHAEL HILLDOERFER
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Regulation Number 880.2420

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Classification Product Code FLN
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Date Received 07/12/2002
Decision Date 08/06/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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