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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837343
Device Name PZ-600 COMPUTERIZED AXIAL TOMOGRAPHY SCANNER
Applicant
Phoenix Medical Electronics
14310 Sullyfield Cir., #200
Chantilly,  VA  22021
Correspondent
Phoenix Medical Electronics
14310 Sullyfield Cir., #200
Chantilly,  VA  22021
Date Received02/28/1983
Decision Date 05/31/1983
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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