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510(k) K110189

REPROCESSED ELECTROSURGICAL INSTRUMENT by Ascent Healthcare Solutions — Product Code NUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2011
Date Received
January 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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