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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K828606
Device Name MODEL PDX-4800 PROJECTION DIGITAL X-RAY SYSTEM
Applicant
Adac Laboratories
Jellingvej 5
9230 Svenstrup
Denmark,  DK
Correspondent
Adac Laboratories
Jellingvej 5
9230 Svenstrup
Denmark,  DK
Date Received11/29/1982
Decision Date 01/03/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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