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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 -4407
Applicant Contact RON THERIOT
Correspondent
INTERWORLD, INC.
1101 KNOLLWOOD DR.
SAFETY HARBOR,  FL  34695 -4407
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
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