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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stabilizer, Heart
510(k) Number K992476
Device Name PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
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 Number870.4500
Classification Product Code
MWS  
Date Received07/26/1999
Decision Date 09/13/2000
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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