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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K924008
Device Name STERILE FILM WOUND DRESSING
Applicant
Innovative Technology , Ltd.
227 Eagle St.
Newmarket
Ontario L3y 1j8,  CA
Applicant Contact DIANE J MITCHELL
Correspondent
Innovative Technology , Ltd.
227 Eagle St.
Newmarket
Ontario L3y 1j8,  CA
Correspondent Contact DIANE J MITCHELL
Classification Product Code
MGP  
Date Received08/10/1992
Decision Date 11/24/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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