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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K101118
Device Name ACTIVON TULLE
Applicant
Calidad Solutions, Inc.
22433 72 Ave. S
Kent,  WA  98032
Applicant Contact JOHN BILLINGS
Correspondent
Calidad Solutions, Inc.
22433 72 Ave. S
Kent,  WA  98032
Correspondent Contact JOHN BILLINGS
Classification Product Code
FRO  
Date Received04/21/2010
Decision Date 12/15/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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