CLOSED WOUND SUCTION DEVICE

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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 Closed Wound Suction Device.

Pre-market Notification Details

Device IDK883472
510k NumberK883472
Device Name:CLOSED WOUND SUCTION DEVICE
ClassificationApparatus, Suction, Single Patient Use, Portable, Nonpowered
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 CodeGCY  
CFR Regulation Number878.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-16
Decision Date1988-10-18

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