FDA 510(k) Application Details - K023227

Device Classification Name Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic

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510(K) Number K023227
Device Name Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
Applicant ULTRAGUIDE LTD.
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS, NJ 07601 US
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Contact GEORGE MYERS
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Regulation Number 884.2225

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Classification Product Code HHJ
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Date Received 09/27/2002
Decision Date 10/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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