FDA 510(k) Application Details - K240910

Device Classification Name Indicator, Physical/Chemical Sterilization Process

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510(K) Number K240910
Device Name Indicator, Physical/Chemical Sterilization Process
Applicant Propper Manufacturing Co., Inc.
36-04 Skillman Avenue
Long Island City, NY 11101 US
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Contact Andrew Sharavara
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Regulation Number 880.2800

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Classification Product Code JOJ
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Date Received 04/02/2024
Decision Date 06/12/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240910


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