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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Suction Operatory
510(k) Number K860058
Device Name DENPAX
Applicant
Nissho Iwai American Corp.
1211 Ave. Of The Americas
New York,  NY  10036
Applicant Contact LIU
Correspondent
Nissho Iwai American Corp.
1211 Ave. Of The Americas
New York,  NY  10036
Correspondent Contact LIU
Regulation Number872.6640
Classification Product Code
EBR  
Date Received01/06/1986
Decision Date 03/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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