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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 K180766
Device Name Endiscope, Endiscope Cervical
Applicant
Elliquence, LLC
2455 Grand Ave.
Baldwin,  NY  11510
Applicant Contact Paul D. Buhrke
Correspondent
Elliquence, LLC
2455 Grand Ave.
Baldwin,  NY  11510
Correspondent Contact Paul D. Buhrke
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/23/2018
Decision Date 06/11/2018
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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