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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Clamp, Vascular
510(k) Number K992174
Device Name PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
Applicant
Pilling Weck Surgical
420 Delaware Dr.
Fort Washington,  PA  19034
Applicant Contact RICHARD G JONES
Correspondent
Pilling Weck Surgical
420 Delaware Dr.
Fort Washington,  PA  19034
Correspondent Contact RICHARD G JONES
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/28/1999
Decision Date 03/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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