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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K922828
Device Name ULCER WOUND TRAY
Applicant
Ulti-Med Intl., Inc.
1688 Glen Ellyn Rd.
Glendale Hts.,  IL  60139
Applicant Contact DAVID INSCO
Correspondent
Ulti-Med Intl., Inc.
1688 Glen Ellyn Rd.
Glendale Hts.,  IL  60139
Correspondent Contact DAVID INSCO
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/12/1992
Decision Date 09/28/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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