ORION STERILE OR TOWELS

Drape, Surgical

ORION LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Orion Sterile Or Towels.

Pre-market Notification Details

Device IDK903117
510k NumberK903117
Device Name:ORION STERILE OR TOWELS
ClassificationDrape, Surgical
Applicant ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling,  IL  60090
ContactJohn L Laemmar
CorrespondentJohn L Laemmar
ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling,  IL  60090
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-16
Decision Date1990-12-31

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