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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 K023783
Device Name SOHNIKS
Applicant
Sohniks Endoscopy, Inc.
930 Blue Gentian Rd.
Suite 1400
Eagan,  MN  55121
Applicant Contact MARC HOSKINS
Correspondent
Sohniks Endoscopy, Inc.
930 Blue Gentian Rd.
Suite 1400
Eagan,  MN  55121
Correspondent Contact MARC HOSKINS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/12/2002
Decision Date 02/07/2003
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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