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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 K852920
Device Name QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF
Applicant
Neuromed, Inc.
5000 A Oakes Rd. Suite A.
Ft. Lauderdale,  FL  33314
Applicant Contact FRANK LISKA
Correspondent
Neuromed, Inc.
5000 A Oakes Rd. Suite A.
Ft. Lauderdale,  FL  33314
Correspondent Contact FRANK LISKA
Regulation Number882.5880
Classification Product Code
GZB  
Date Received07/10/1985
Decision Date 10/10/1985
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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