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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 K914245
Device Name DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
Applicant
DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE,  MA  02762
Applicant Contact EGIDIA M VERGANO
Correspondent
DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE,  MA  02762
Correspondent Contact EGIDIA M VERGANO
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/23/1991
Decision Date 12/09/1991
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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