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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 K962740
Device Name DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
Applicant
Medi-Flex Hospital Products, Inc.
19 Butterfield Trl.
El Paso,  TX  79906
Applicant Contact THOMAS VANNE
Correspondent
Medi-Flex Hospital Products, Inc.
19 Butterfield Trl.
El Paso,  TX  79906
Correspondent Contact THOMAS VANNE
Regulation Number880.5090
Classification Product Code
KMF  
Date Received07/15/1996
Decision Date 09/06/1996
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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