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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K970441
Device Name K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
Applicant
Medi-Flex Hospital Products, Inc.
8717 W. 110th St., Suite 750
Overland Park,  KS  66210 -2103
Applicant Contact PAT MCGRATH
Correspondent
Medi-Flex Hospital Products, Inc.
8717 W. 110th St., Suite 750
Overland Park,  KS  66210 -2103
Correspondent Contact PAT MCGRATH
Regulation Number880.5240
Classification Product Code
FPX  
Date Received02/05/1997
Decision Date 05/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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