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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K921319
Device Name NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
Applicant
Neuromed, Inc.
5000-A Oakes Rd., Suite A
Ft. Lauderdale,  FL  33314
Applicant Contact DEAN E CIPORKIN
Correspondent
Neuromed, Inc.
5000-A Oakes Rd., Suite A
Ft. Lauderdale,  FL  33314
Correspondent Contact DEAN E CIPORKIN
Regulation Number882.5880
Classification Product Code
GZB  
Date Received03/19/1992
Decision Date 05/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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