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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 K880548
Device Name SAFE-STRIPS
Applicant
Medstar, Inc.
4216 Commercial Way
Glenview,  IL  60025
Applicant Contact RON GAGNIER
Correspondent
Medstar, Inc.
4216 Commercial Way
Glenview,  IL  60025
Correspondent Contact RON GAGNIER
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/09/1988
Decision Date 09/29/1988
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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