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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 K080122
Device Name SOPRO 670 ARTHROSCOPIC PUMP
Applicant
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Applicant Contact STEVE SALESKY
Correspondent
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact STEVE SALESKY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/17/2008
Decision Date 07/11/2008
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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