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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 K910436
Device Name ELASTIC ADHESIVE BANDAGE
Applicant
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Applicant Contact ECONOMIDY, JR.
Correspondent
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Correspondent Contact ECONOMIDY, JR.
Regulation Number880.5240
Classification Product Code
KGX  
Date Received01/31/1991
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
Predetermined Change
Control Plan Authorized		 No
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