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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 K853702
Device Name ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN
Applicant
Johnson & Johnson Professionals, Inc.
69 Spring St.
Ramsey,  NJ  07446
Applicant Contact RAYMOND F CHASE
Correspondent
Johnson & Johnson Professionals, Inc.
69 Spring St.
Ramsey,  NJ  07446
Correspondent Contact RAYMOND F CHASE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/04/1985
Decision Date 02/13/1986
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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