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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Nonfetal
510(k) Number K912925
Device Name ULTRA PVD
Applicant
Advanced Medical Products, Inc.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact DONALD R STONE
Correspondent
Advanced Medical Products, Inc.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact DONALD R STONE
Regulation Number892.1540
Classification Product Code
JAF  
Date Received07/03/1991
Decision Date 06/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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