SURGICAL CONNECTING TUBES

Tubing, Noninvasive

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 Surgical Connecting Tubes.

Pre-market Notification Details

Device IDK883473
510k NumberK883473
Device Name:SURGICAL CONNECTING TUBES
ClassificationTubing, Noninvasive
Applicant WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids,  MI  49507
ContactTim Sagers
CorrespondentTim Sagers
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids,  MI  49507
Product CodeGAZ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-16
Decision Date1988-08-25

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