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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K212592
Device Name Gas-Chex Indicator
Applicant
Propper Manufacturing Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Applicant Contact Andrew Sharavara
Correspondent
Propper Manufacturing Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Correspondent Contact Andrew Sharavara
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/16/2021
Decision Date 01/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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