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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 K870092
Device Name MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM
Applicant
AVERY INTL.
FASSON MEDICAL PRODUCTS
7100 LINDSAY DRIVE
MENTOR,  OH  44060
Applicant Contact HOWARD T COOPER
Correspondent
AVERY INTL.
FASSON MEDICAL PRODUCTS
7100 LINDSAY DRIVE
MENTOR,  OH  44060
Correspondent Contact HOWARD T COOPER
Regulation Number880.5240
Classification Product Code
KGX  
Date Received01/09/1987
Decision Date 02/05/1987
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
Predetermined Change
Control Plan Authorized		 No
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