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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape and bandage, adhesive
510(k) Number K904904
Device Name MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION
Applicant
GRAHAM-FIELD, INC.
400 RABRO DR. EAST
HAUPPAUGE,  NY  11788
Applicant Contact MARIA SIMAT
Correspondent
GRAHAM-FIELD, INC.
400 RABRO DR. EAST
HAUPPAUGE,  NY  11788
Correspondent Contact MARIA SIMAT
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/30/1990
Decision Date 03/19/1991
Decision Substantially Equivalent (SESE)
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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