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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 K161358
Device Name Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
Applicant
Surgical Instrument Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact BRANDI J. PANTELEON
Correspondent
Surgical Instrument Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact BRANDI J. PANTELEON
Regulation Number878.4780
Classification Product Code
JCX  
Date Received05/16/2016
Decision Date 08/03/2017
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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