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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solvent, adhesive tape
510(k) Number K934790
Device Name SEPP ADHESIVE REMOVER
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 Number878.4730
Classification Product Code
KOX  
Date Received10/05/1993
Decision Date 03/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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