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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 K953019
Device Name HYDROPHILIC FOAM DRESSING
Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Applicant Contact EILEEN RAMA
Correspondent
BUSSE HOSPITAL DISPOSABLES, INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Correspondent Contact EILEEN RAMA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/29/1995
Decision Date 09/15/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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