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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803137631 Fetal Spiral Electrode
Classification Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
Product Code: HGP
Device Class: 2
Regulation Number: 884.2675
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K030691
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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