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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K895727
Device Name BACKGROUND SUCTION MATT
Applicant
Applied Medical Technologies, Inc.
6551 Brecksville Rd.
Independence,  OH  44131
Applicant Contact DEAN SECREST
Correspondent
Applied Medical Technologies
6551 Brecksville Rd.
Independence,  OH  44131
Correspondent Contact DEAN SECREST
Regulation Number878.4014
Classification Product Code
NAB  
Date Received09/25/1989
Decision Date 10/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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