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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K043287
Device Name PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000
Applicant
Micromedical Devices, Inc.
5308 Derry Ave., Suite I-204
Agoura Hills,  CA  91301
Applicant Contact RAFI ISRAEL
Correspondent
California Department of Health Services
1500 Capitol Ave.
Mailstop 7602
Sacramento,  CA  95814
Correspondent Contact ALFREDO J QUATTRONE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/29/2004
Decision Date 12/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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