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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837111
Device Name X RAY TUBE HOUSING/INSERT
Applicant
Atlantic Imaging Corp.
21 Everett St.
Woburn,  MA  01801
Correspondent
Atlantic Imaging Corp.
21 Everett St.
Woburn,  MA  01801
Date Received12/27/1982
Decision Date 03/09/1983
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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