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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K022752
Device Name PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
Applicant
HDC CORP.
628 GIBRALTAR COURT
MILPITAS,  CA  95035
Applicant Contact EARL SMART
Correspondent
HDC CORP.
628 GIBRALTAR COURT
MILPITAS,  CA  95035
Correspondent Contact EARL SMART
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received08/19/2002
Decision Date 09/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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