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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K983554
Device Name ALLDRESS, ABSORBENT FILM DRESSING
Applicant
MOLNLYCKE HEALTH CARE, INC.
500 BALDWIN TOWER
EDDYSTONE,  PA  19022
Applicant Contact MIGUEL A NEGRON
Correspondent
MOLNLYCKE HEALTH CARE, INC.
500 BALDWIN TOWER
EDDYSTONE,  PA  19022
Correspondent Contact MIGUEL A NEGRON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/13/1998
Decision Date 11/10/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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