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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 K132671
Device Name STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49001
Applicant Contact MICHELLE JUMP
Correspondent
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49001
Correspondent Contact MICHELLE JUMP
Regulation Number878.4780
Classification Product Code
JCX  
Subsequent Product Code
FYD  
Date Received08/27/2013
Decision Date 12/20/2013
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
Recalls CDRH Recalls
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