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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K962771
Device Name BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
Applicant
Pilling Weck, Inc.
420 Delaware Dr.
Fort Washington,  PA  19034
Applicant Contact RICHARD G JONES
Correspondent
Pilling Weck, Inc.
420 Delaware Dr.
Fort Washington,  PA  19034
Correspondent Contact RICHARD G JONES
Regulation Number870.4500
Classification Product Code
DWS  
Date Received07/16/1996
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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