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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 K002365
Device Name DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
Applicant
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Applicant Contact JOANN WOLF
Correspondent
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Correspondent Contact JOANN WOLF
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/03/2000
Decision Date 08/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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