CATHETER PLUG/PROTECTOR

Accessories, Catheter, G-u

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 Catheter Plug/protector.

Pre-market Notification Details

Device IDK896806
510k NumberK896806
Device Name:CATHETER PLUG/PROTECTOR
ClassificationAccessories, Catheter, G-u
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 CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-01
Decision Date1990-02-26

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