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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 K860307
Device Name PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET
Applicant
TELEFLEX, INC.
TALL PINES PARK
JEFFREY,  NH  03452
Applicant Contact GARY BULLARD
Correspondent
TELEFLEX, INC.
TALL PINES PARK
JEFFREY,  NH  03452
Correspondent Contact GARY BULLARD
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/28/1986
Decision Date 05/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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