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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827176
Device Name MODEL 640 LINEAR SCANNER
Applicant
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Correspondent
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Date Received11/02/1982
Decision Date 12/14/1982
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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