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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 K082910
Device Name CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES
Applicant
Aso, LLC
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact JONATHAN WARD
Correspondent
Aso, LLC
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact JONATHAN WARD
Classification Product Code
FRO  
Date Received09/30/2008
Decision Date 06/17/2009
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized
No
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