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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, Accessories
510(k) Number K042266
Device Name ACCLAIM
Applicant
Air Techniques, Inc.
70 Cantiague Rock Rd.
Hicksville,  NY  11801
Applicant Contact JOSEPH CAREY
Correspondent
Air Techniques, Inc.
70 Cantiague Rock Rd.
Hicksville,  NY  11801
Correspondent Contact JOSEPH CAREY
Regulation Number872.6640
Classification Product Code
NRD  
Subsequent Product Code
EAY  
Date Received08/23/2004
Decision Date 08/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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