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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K884946
Device Name JEHLE CORONARY PERFUSION CATHETERS
Applicant
Pilling Co.
420 Delaware Dr.
Fort Washington,  PA  19034
Applicant Contact LELAND J WIMER
Correspondent
Pilling Co.
420 Delaware Dr.
Fort Washington,  PA  19034
Correspondent Contact LELAND J WIMER
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/28/1988
Decision Date 02/06/1989
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
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