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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K861165
Device Name PHARMASEAL DUAL LUMEN CATHETER
Applicant
AMERICAN PHARMASEAL DIV. AHSC
27200 NORTH TOURNEY RD.
POST OFFICE BOX 5900
VALENCIA,  CA  91355
Applicant Contact LARRY W GETLIN
Correspondent
AMERICAN PHARMASEAL DIV. AHSC
27200 NORTH TOURNEY RD.
POST OFFICE BOX 5900
VALENCIA,  CA  91355
Correspondent Contact LARRY W GETLIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/28/1986
Decision Date 05/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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