IRRIGATION TRAY

Syringe, Irrigating (non Dental)

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 Irrigation Tray.

Pre-market Notification Details

Device IDK896800
510k NumberK896800
Device Name:IRRIGATION TRAY
ClassificationSyringe, Irrigating (non Dental)
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 CodeKYZ  
CFR Regulation Number880.6960 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-01
Decision Date1990-05-24

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