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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K933455
Device Name COMPUTED ORAL RADIOLOGY SYSTEM
Applicant
Schick Technologies, Inc.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
Schick Technologies, Inc.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number872.1810
Classification Product Code
EAP  
Date Received07/14/1993
Decision Date 01/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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