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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 K982797
Device Name BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
Applicant
Luther Medical Products, Inc.
14332 Chambers Rd.
Tustin,  CA  92780 -6912
Applicant Contact KATHLEEN ROBERTS
Correspondent
Luther Medical Products, Inc.
14332 Chambers Rd.
Tustin,  CA  92780 -6912
Correspondent Contact KATHLEEN ROBERTS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/10/1998
Decision Date 11/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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