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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K921347
Device Name CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
Applicant
MEDI-FLEX HOSPITAL PRODUCTS, INC.
8717 W. 110TH ST., SUITE 750
OVERLAND PARK,  KS  66210 -2103
Applicant Contact ORLANDO CORDOVA
Correspondent
MEDI-FLEX HOSPITAL PRODUCTS, INC.
8717 W. 110TH ST., SUITE 750
OVERLAND PARK,  KS  66210 -2103
Correspondent Contact ORLANDO CORDOVA
Regulation Number880.5075
Classification Product Code
MCY  
Date Received03/18/1992
Decision Date 01/08/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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