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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K971062
Device Name OPPORTUNITY INC. GENERAL PURPOSE TRAY
Applicant
Opportunity, Inc.
1200 Old Skokie Rd.
Highland Park,  IL  60035
Applicant Contact JAMES S SANDERS
Correspondent
Opportunity, Inc.
1200 Old Skokie Rd.
Highland Park,  IL  60035
Correspondent Contact JAMES S SANDERS
Regulation Number878.4370
Classification Product Code
LRO  
Date Received03/24/1997
Decision Date 06/09/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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