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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K984584
Device Name AIR TECHNIQUES' DENTO-VAC
Applicant
Air Techniques, Inc.
70 Cantiague Rock Rd.
Hicksville,  NY  11802
Applicant Contact JOSEPH CAREY
Correspondent
Air Techniques, Inc.
70 Cantiague Rock Rd.
Hicksville,  NY  11802
Correspondent Contact JOSEPH CAREY
Regulation Number872.6640
Classification Product Code
EIA  
Date Received12/24/1998
Decision Date 03/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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