MERCY HIP/KNEE PACK

Drape, Surgical

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 Mercy Hip/knee Pack.

Pre-market Notification Details

Device IDK896215
510k NumberK896215
Device Name:MERCY HIP/KNEE PACK
ClassificationDrape, Surgical
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 CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-26
Decision Date1990-02-13

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