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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, Extraoral With Timer
510(k) Number K894935
Device Name S-70 PORTABLE DENTAL X-RAY SYSTEM
Applicant
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Applicant Contact EDWARD MCDERMOTT
Correspondent
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Correspondent Contact EDWARD MCDERMOTT
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/03/1989
Decision Date 04/25/1990
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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