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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K183613
Device Name exGraft, exGraft Carbon
Applicant
Peca Labs
4424 Penn Ave.
Suite 201
Pittsburgh,  PA  15224
Applicant Contact Doug Bernstein
Correspondent
Peca Labs
4424 Penn Ave.
Suite 201
Pittsburgh,  PA  15224
Correspondent Contact Doug Bernstein
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/26/2018
Decision Date 04/22/2019
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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