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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 K924516
Device Name OP3/VP4
Applicant
Huntleigh Technology, Inc.
227 Route 33 E.
Manalapan,  NJ  07726
Applicant Contact ANDY WOOD
Correspondent
Huntleigh Technology, Inc.
227 Route 33 E.
Manalapan,  NJ  07726
Correspondent Contact ANDY WOOD
Regulation Number884.2960
Classification Product Code
HGL  
Date Received09/04/1992
Decision Date 06/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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