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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, salpingography
510(k) Number K932436
Device Name ECHOMARK INTRAUTERINE GUIDING CATHETER
Applicant
ECHOCATH, INC.
P.O. BOX 7224
PRINCETON,  NJ  08543 -7224
Applicant Contact FRANK DEBERNARDIS
Correspondent
ECHOCATH, INC.
P.O. BOX 7224
PRINCETON,  NJ  08543 -7224
Correspondent Contact FRANK DEBERNARDIS
Regulation Number884.4530
Classification Product Code
MOV  
Date Received05/19/1993
Decision Date 11/16/1995
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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