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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 K860697
Device Name ULTRASOUND IMAGING SYSTEM MODEL 280 SL
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 Received02/25/1986
Decision Date 07/24/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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