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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Obstetric
510(k) Number K860313
Device Name 3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
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 Number884.2960
Classification Product Code
HGL  
Date Received01/28/1986
Decision Date 03/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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