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FDA 510(k) Application Details - K992341
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
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510(K) Number
K992341
Device Name
Indicator, Physical/Chemical Sterilization Process
Applicant
SERIM RESEARCH CORP.
23565 REEDY DR.
ELKHART, IN 46514 US
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Contact
JAMES E CHRISTNER
Other 510(k) Applications for this Contact
Regulation Number
880.2800
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Classification Product Code
JOJ
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More FDA Info for this Product Code
Date Received
07/13/1999
Decision Date
11/23/1999
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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