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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
Contact seth schulman
Regulation Number878.4780
Classification Product Code
JCX  
Date Received09/07/2012
Decision Date 10/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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