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510(k) K934790

Device
SEPP ADHESIVE REMOVER
Applicant
MEDI-FLEX HOSPITAL PRODUCTS, INC.
510(k) number
K934790
Product code
KOX  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-11
Date received
1993-10-05
Regulation
878.4730
Classification name
Solvent, Adhesive Tape
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ORLANDO CORDOVA
Address
8717 W. 110th St., Suite 750 Overland Park KS US 66210 66210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KOX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931933CHAD LABS ADHESIVE BANDAGE REMOVERChad Labs Corp.1993-07-08
K924976ALLKARE(TM) ADHESIVE REMOVER WIPEConvatec, A Division of E.R. Squibb & Sons1993-04-20
K924571MEDI-SOLOrange-Sol, Inc.1993-04-06
K9256183M REMOVER LOTION PRODUCT NUMBER 86XX3M Health Care, Ltd.1993-03-31
K923351SKIN SUPPORT PREP PADColoplast Corp.1992-09-14
K915150REMOVE ADHESIVE REMOVERSmith & Nephew United, Inc.1992-01-09
K902009ELANTEC'S SURGICAL TAPE REMOVERElantec, Inc.1990-08-29
K895293KEMI LABS - ADHESIVE BANDAGE REMOVERKemi Labs, Inc.1990-02-09
K893603REMOVE ADHESIVE REMOVERSmith & Nephew United, Inc.1989-07-14
K881359DECALCIFYING SOLUTION IIStephens Scientific1988-04-19
K821162ADHESIVE REMOVERThe Healthcare Group Laboratories, Inc.1982-05-14

Legacy Summary#

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FDA Review#

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