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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K250306
Device Name Chex-All Sterilization Pouches and Tubes
Applicant
Propper Manufacturing Co, Inc.
36-04 Skillman Avenue
Long Island City,  NY  11101
Applicant Contact Andrew Sharavara
Correspondent
Propper Manufacturing Co, Inc.
36-04 Skillman Avenue
Long Island City,  NY  11101
Correspondent Contact Andrew Sharavara
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received02/03/2025
Decision Date 10/31/2025
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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