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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Fiber, Medical, Absorbent
510(k) Number K110715
Device Name INTERDRY SILVER
Applicant
Milliken Healthcare Products, LLC
920 Milliken Rd.
Spartanburg,  SC  29303
Applicant Contact BRIAN J LINDSAY
Correspondent
Milliken Healthcare Products, LLC
920 Milliken Rd.
Spartanburg,  SC  29303
Correspondent Contact BRIAN J LINDSAY
Regulation Number880.5300
Classification Product Code
FRL  
Date Received03/15/2011
Decision Date 11/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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