UNIVERSAL POOLE SUCTION TUBE

Apparatus, Suction, Operating-room, Wall Vacuum Powered

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 Universal Poole Suction Tube.

Pre-market Notification Details

Device IDK896556
510k NumberK896556
Device Name:UNIVERSAL POOLE SUCTION TUBE
ClassificationApparatus, Suction, Operating-room, Wall Vacuum Powered
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 CodeGCX  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-17
Decision Date1990-02-06

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