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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 K123904
Device Name PROTHELIAL
Applicant
Mueller Medical International, LLC
48a Moosup Valley Rd.
Foster,  RI  02825
Applicant Contact RICKY W MCCULLOUGH MD
Correspondent
Mueller Medical International, LLC
48a Moosup Valley Rd.
Foster,  RI  02825
Correspondent Contact RICKY W MCCULLOUGH MD
Classification Product Code
FRO  
Date Received12/19/2012
Decision Date 08/07/2013
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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