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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 K153407
Device Name Stryker Neptune 3 Waste Management System
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49001
Applicant Contact KIM WIERSEMA
Correspondent
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49001
Correspondent Contact KIM WIERSEMA
Regulation Number878.4780
Classification Product Code
JCX  
Subsequent Product Code
FYD  
Date Received11/25/2015
Decision Date 04/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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