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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 K093320
Device Name DRYODINE CADEXOMER-IODINE GEL
Applicant
Collegium Pharmaceutical Incorporated
400 Highland Corporate Dr.
Cumberland,  RI  02864
Applicant Contact MARK W TRUMBORE
Correspondent
Collegium Pharmaceutical Incorporated
400 Highland Corporate Dr.
Cumberland,  RI  02864
Correspondent Contact MARK W TRUMBORE
Classification Product Code
FRO  
Date Received10/23/2009
Decision Date 06/18/2010
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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