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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Graduated Electronic Decelerator
Classification Name: DEVICE, AVERSIVE CONDITIONING
Product Code: HCB
Device Class: 2
Regulation Number: 882.5235
Medical Specialty: Neurology
Registered Establishment Name: THE JUDGE ROTENBERG EDUCATIONAL CENTER, INC.
Registered Establishment Number: 1222743
Premarket Submission Number: K911820
Owner/Operator: THE JUDGE ROTENBERG EDUCATIONAL CENTER, INC.
Owner/Operator Number: 9003264
Establishment Operations: Manufacturer
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