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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K990333
Device Name MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
Applicant
MEDTRONIC PS MEDICAL
125 CREMONA DR.
GOLETA,  CA  93117 -5500
Applicant Contact JEFFREY HENDERSON
Correspondent
MEDTRONIC PS MEDICAL
125 CREMONA DR.
GOLETA,  CA  93117 -5500
Correspondent Contact JEFFREY HENDERSON
Regulation Number882.1480
Classification Product Code
GWG  
Date Received02/03/1999
Decision Date 04/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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