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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 K934205
Device Name SEARCH-SONIC
Applicant
Altana, Inc.
60 Baylis Rd.
Melville,  NY  11747
Applicant Contact STEVEN W BROWN
Correspondent
Altana, Inc.
60 Baylis Rd.
Melville,  NY  11747
Correspondent Contact STEVEN W BROWN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/30/1993
Decision Date 06/21/1994
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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