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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, suturing, disposable
510(k) Number K895681
Device Name CONTRAST BACKGROUND MATERIAL
Applicant
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Applicant Contact DEAN SECREST
Correspondent
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Correspondent Contact DEAN SECREST
Regulation Number878.4800
Classification Product Code
GAB  
Date Received09/21/1989
Decision Date 10/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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