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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Bivalve Splint Std; Neiman Sil RB Nasal Splint; Spetal Splint Std
Classification Name: SPLINT, INTRANASAL SEPTAL
Product Code: LYA
Device Class: 1
Regulation Number: 874.4780
Medical Specialty: Ear Nose & Throat
Registered Establishment Name: Gyrus ACMI, Inc.
Registered Establishment Number: 3011050570
Owner/Operator: OLYMPUS CORPORATION
Owner/Operator Number: 9067818
Establishment Operations: Complaint File Establishment
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