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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803196341 Avalon CL Fetal & Maternal Patch
Classification Name: UTERINE ELECTROMYOGRAPHIC MONITOR
Product Code: OSP
Device Class: 2
Regulation Number: 884.2720
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K140862
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Repackager/Relabeler
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