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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K233115
Device Name Hawkeye Control Unit with Eyas Endoscope
Applicant
E Surgical, LLC
150 Isidor Court
Suite 203
Sparks,  NV  89441
Applicant Contact Michael Blomeyer
Correspondent
Coombs Medical Device Consulting, Inc.
427 14th Ave.
San Francisco,  CA  94118
Correspondent Contact Craig Coombs
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/27/2023
Decision Date 02/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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