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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K122756
Device Name PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
Applicant
PENUMBRA, INC.
1351 HARBOR BAY PARKWAY
ALAMEDA,  CA  94502
Applicant Contact SETH SCHULMAN
Correspondent
PENUMBRA, INC.
1351 HARBOR BAY PARKWAY
ALAMEDA,  CA  94502
Correspondent Contact SETH SCHULMAN
Regulation Number878.4780
Classification Product Code
JCX  
Date Received09/07/2012
Decision Date 10/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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