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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827450
Device Name SIMPLAMATIC III
Applicant
Spectrum X-Ray Corp.
P.O. Box 155 Ryan Ave.
Westville,  NJ  08093
Correspondent
Spectrum X-Ray Corp.
P.O. Box 155 Ryan Ave.
Westville,  NJ  08093
Date Received04/27/1982
Decision Date 05/19/1982
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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