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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, aversive conditioning
510(k) Number K853178
Device Name SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM
Applicant
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Applicant Contact JOHN K LAURIE
Correspondent
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Correspondent Contact JOHN K LAURIE
Regulation Number882.5235
Classification Product Code
HCB  
Date Received07/30/1985
Decision Date 02/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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