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510(k) K171840

Stryker Consolidated Operating Room Equipment (CORE) 2 Console by Stryker Corporation — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2017
Date Received
June 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

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