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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Oral Cavity
510(k) Number K864621
Device Name VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER
Applicant
Seldoren , Ltd.
International Marketing Cons.
230 Park Ave., Suite 917
New York,  NY  10136
Applicant Contact DEREK RAWDEN
Correspondent
Seldoren , Ltd.
International Marketing Cons.
230 Park Ave., Suite 917
New York,  NY  10136
Correspondent Contact DEREK RAWDEN
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received11/24/1986
Decision Date 02/13/1987
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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