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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K872117
Device Name DEXTRANOMER
Applicant
Interworld, Inc.
1101 Knollwood Dr.
Safety Harbor,  FL  34695
Applicant Contact RON THERIOT
Correspondent
Interworld, Inc.
1101 Knollwood Dr.
Safety Harbor,  FL  34695
Correspondent Contact RON THERIOT
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received06/01/1987
Decision Date 07/24/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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