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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K871132
Device Name PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
Applicant
DELTEC SYSTEMS, INC.
1265 GREY FOX RD.
ST PAUL,  MN  55112
Applicant Contact W NUMAINVILLE
Correspondent
DELTEC SYSTEMS, INC.
1265 GREY FOX RD.
ST PAUL,  MN  55112
Correspondent Contact W NUMAINVILLE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/20/1987
Decision Date 04/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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