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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K873178
Device Name URETERAL BULB DILATORS
Applicant
PENN MEDICAL DEVICES, INC.
12 RIDGE ST.
BASKING RIDGE,  NJ  07920
Applicant Contact CHARLES E MEISCH
Correspondent
PENN MEDICAL DEVICES, INC.
12 RIDGE ST.
BASKING RIDGE,  NJ  07920
Correspondent Contact CHARLES E MEISCH
Regulation Number876.5470
Classification Product Code
EZN  
Date Received08/12/1987
Decision Date 09/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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