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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K042359
Device Name SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
Applicant
Medical Designs, LLC
1210 W. 18th St.
North Center, Suite 104
Sioux Falls,  SD  57104
Applicant Contact PAUL JOHN AXT
Correspondent
Medical Designs, LLC
1210 W. 18th St.
North Center, Suite 104
Sioux Falls,  SD  57104
Correspondent Contact PAUL JOHN AXT
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/31/2004
Decision Date 11/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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