PROSTATIC URETHRO. BALLOON DILATATION CATHETER

Dilator, Urethral

MEDI-TECH, INC.

The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Prostatic Urethro. Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK873295
510k NumberK873295
Device Name:PROSTATIC URETHRO. BALLOON DILATATION CATHETER
ClassificationDilator, Urethral
Applicant MEDI-TECH, INC. 480 PLESANT ST. P.O. BOX 7407 Watertown,  MA  02272
ContactAlbert P Seprinski
CorrespondentAlbert P Seprinski
MEDI-TECH, INC. 480 PLESANT ST. P.O. BOX 7407 Watertown,  MA  02272
Product CodeKOE  
CFR Regulation Number876.5520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-17
Decision Date1989-07-31

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