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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Classification Name: DEVICE, ANTI-SNORING
Product Code: LRK
Device Class: 2
Regulation Number: 872.5570
Medical Specialty: Dental
Registered Establishment Name: 3DPX MEDICAL
Registered Establishment Number: 3017567754
Premarket Submission Number: K203606
Owner/Operator: 3DPX Medical
Owner/Operator Number: 10078770
Establishment Operations: Contract Manufacturer
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