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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K883880
Device Name KATZEN THROMBOLYSIS GUIDEWIRE
Applicant
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact ALBERT SEPRINSKI
Correspondent
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact ALBERT SEPRINSKI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/13/1988
Decision Date 04/06/1989
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
Recalls CDRH Recalls
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