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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K051758
Device Name PENUMBRA ASPIRATION PUMP, MODEL 115V
Applicant
Penumbra, Inc.
2401 Merced St.
Suite 200
San Leandro,  CA  94577
Applicant Contact THERESA B BRANDNER-ALLEN
Correspondent
Penumbra, Inc.
2401 Merced St.
Suite 200
San Leandro,  CA  94577
Correspondent Contact THERESA B BRANDNER-ALLEN
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
JCX  
Date Received06/29/2005
Decision Date 08/17/2005
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
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