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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 K895910
Device Name STEAMLINE
Applicant
Propper Mfg. Co., Inc.
3604 Skillman Ave.
Long Island City,  NY  11101
Applicant Contact PLATKO, PHD
Correspondent
Propper Mfg. Co., Inc.
3604 Skillman Ave.
Long Island City,  NY  11101
Correspondent Contact PLATKO, PHD
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received10/10/1989
Decision Date 08/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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