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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bandage, liquid
510(k) Number K971091
Device Name OPPURTUNITY TRACHEOSTOMY CARE KIT
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 Number880.5090
Classification Product Code
KMF  
Date Received03/24/1997
Decision Date 09/16/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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