510(k) K161358

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds by Surgical Instrument Service and Savings, Inc. — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2017
Date Received
May 16, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type