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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 K854591
Device Name SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
Applicant
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Applicant Contact WILLIAM G MCMAHON
Correspondent
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.1540
Classification Product Code
JAF  
Date Received11/18/1985
Decision Date 04/23/1986
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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