MAGNET PAD

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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 Magnet Pad.

Pre-market Notification Details

Device IDK896802
510k NumberK896802
Device Name:MAGNET PAD
ClassificationEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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 CodeLXG  
CFR Regulation Number862.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-01
Decision Date1989-12-27

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