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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 K910657
Device Name QUALTEX ISLAND DRESSING
Applicant
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number880.5240
Classification Product Code
KGX  
Date Received02/14/1991
Decision Date 07/01/1991
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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