URETHRAL CATHETERIZATION TRAYS

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)

The following data is part of a premarket notification filed by Westmark, Sterile Packing Systems, Inc. (sps) with the FDA for Urethral Catheterization Trays.

Pre-market Notification Details

Device IDK896212
510k NumberK896212
Device Name:URETHRAL CATHETERIZATION TRAYS
ClassificationTray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Applicant WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids,  MI  49507
ContactSury Shoney
CorrespondentSury Shoney
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids,  MI  49507
Product CodeFCM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-26
Decision Date1990-01-24

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