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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 K874242
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 Received10/16/1987
Decision Date 12/07/1987
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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