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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K090385
Device Name LARIAT II SUTURE DELIVERY DEVICE
Applicant
SENTREHEART INC.
2468 EMBARCADERO WAY
PALO ALTO,  CA  94303
Applicant Contact LINDA GUTHRIE
Correspondent
SENTREHEART INC.
2468 EMBARCADERO WAY
PALO ALTO,  CA  94303
Correspondent Contact LINDA GUTHRIE
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
HCF  
Date Received02/17/2009
Decision Date 05/06/2009
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
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