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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K082725
Device Name GRAFTGUARD PRESSURE CONTROLLING SYRINGE
Applicant
Maquet Cardiovascular, LLC
170 Baytech Dr.
San Jose,  CA  95134
Applicant Contact CHRISTINA L ROWE
Correspondent
Maquet Cardiovascular, LLC
170 Baytech Dr.
San Jose,  CA  95134
Correspondent Contact CHRISTINA L ROWE
Regulation Number878.4200
Classification Product Code
GBX  
Date Received09/17/2008
Decision Date 12/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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