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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Camera, Surgical
510(k) Number K850122
Device Name SONI-LOK SCOPE STABILIZER
Applicant
Med Surg Designs, Inc.
124 Parker Court
Chardon,  OH  44024
Correspondent
Med Surg Designs, Inc.
124 Parker Court
Chardon,  OH  44024
Regulation Number878.4160
Classification Product Code
FXR  
Date Received01/14/1985
Decision Date 02/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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