PARACERVICAL/PUDENDAL TRAYS

Anesthesia Conduction 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 Paracervical/pudendal Trays.

Pre-market Notification Details

Device IDK896799
510k NumberK896799
Device Name:PARACERVICAL/PUDENDAL TRAYS
ClassificationAnesthesia Conduction 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 CodeCAZ  
CFR Regulation Number868.5140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-01
Decision Date1990-04-23

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