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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K843558
Device Name DELTANODE, MEGA DELTA, DELTA LINK-
Applicant
Computer Design & Applications, Inc.
411 Waverly Oaks Rd.
Waltham ,  MA  02154
Applicant Contact LESLIE A CLARK
Correspondent
Computer Design & Applications, Inc.
411 Waverly Oaks Rd.
Waltham ,  MA  02154
Correspondent Contact LESLIE A CLARK
Regulation Number892.1100
Classification Product Code
IYX  
Date Received09/10/1984
Decision Date 11/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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