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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K992560
Device Name MAPS 10000
Applicant
Web Link Medical
11800 Baltimore Ave.
Suite 105
Beltsville,  MD  20850
Applicant Contact MELISSA MAHALL
Correspondent
Web Link Medical
11800 Baltimore Ave.
Suite 105
Beltsville,  MD  20850
Correspondent Contact MELISSA MAHALL
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/02/1999
Decision Date 10/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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