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510(k) K180949

Steribite by Rjr Surgical, Inc. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2018
Date Received
April 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

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