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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 Doppler, Ultrasonic
510(k) Number K882015
Device Name TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM
Applicant
Ultramed, Inc.
2549 U.S. Rte. 1 Rd. #1
North Brunswick,  NJ  08902
Applicant Contact DAVID VILKOMERSON
Correspondent
Ultramed, Inc.
2549 U.S. Rte. 1 Rd. #1
North Brunswick,  NJ  08902
Correspondent Contact DAVID VILKOMERSON
Regulation Number892.1550
Classification Product Code
IYN  
Date Received05/13/1988
Decision Date 09/08/1988
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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