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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: DEKA Arm System
Classification Name: UPPER EXTREMITY PROSTHESIS WITH MULTIPLE SIMULTANEOUS DEGREES OF FREEDOM AND CONTROLLED VIA CUTANEOUS ELECTROMYOGRAPHY
Product Code: PAE
Device Class: 2
Regulation Number: 890.3450
Medical Specialty: Physical Medicine
Registered Establishment Name: DEKA RESEARCH & DEVELOPMENT CORP.
Registered Establishment Number: 1220973
Premarket Submission Number: DEN120016
Owner/Operator: DEKA Research & Development Corp.
Owner/Operator Number: 10041884
Establishment Operations: Specification Developer
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