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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 K931725
Device Name ALPHA II
Applicant
Dynarad Corp.
19 Jefryn Blvd. W.
Deer Park,  NY  11729
Applicant Contact LEONARD MICHAELS
Correspondent
Dynarad Corp.
19 Jefryn Blvd. W.
Deer Park,  NY  11729
Correspondent Contact LEONARD MICHAELS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received04/05/1993
Decision Date 07/14/1993
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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