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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K873295
Device Name PROSTATIC URETHRO. BALLOON DILATATION CATHETER
Applicant
MEDI-TECH, INC.
480 PLESANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Applicant Contact ALBERT P SEPRINSKI
Correspondent
MEDI-TECH, INC.
480 PLESANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Correspondent Contact ALBERT P SEPRINSKI
Regulation Number876.5520
Classification Product Code
KOE  
Date Received08/17/1987
Decision Date 07/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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