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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Paddie
510(k) Number K014268
Device Name NORAPAD PLAIN; NORAPAD TA
Applicant
Perlei Medical, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ART WARD
Correspondent
Perlei Medical, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ART WARD
Regulation Number882.4700
Classification Product Code
HBA  
Date Received12/27/2001
Decision Date 03/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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