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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K971088
Device Name OPPORTUNITY INCISION AND DRAINAGE 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
Classification Product Code
EFQ  
Date Received03/24/1997
Decision Date 09/16/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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