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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Sinus
510(k) Number K896630
Device Name SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM
Applicant
Atos Medical AB
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact R. J SLOMOFF
Correspondent
Atos Medical AB
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact R. J SLOMOFF
Regulation Number878.4800
Classification Product Code
KAM  
Date Received11/22/1989
Decision Date 06/06/1990
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
Predetermined Change
Control Plan Authorized		 No
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