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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 K943204
Device Name VISTACAM
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 Received07/05/1994
Decision Date 03/16/1995
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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