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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K953289
Device Name TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
Applicant
Davis & Geck, Inc.
One Casper St.
Danbury,  CT  06810
Applicant Contact LYNNE A NEWQUIST
Correspondent
Davis & Geck, Inc.
One Casper St.
Danbury,  CT  06810
Correspondent Contact LYNNE A NEWQUIST
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/14/1995
Decision Date 08/21/1995
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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