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510(k) K924976

Device
ALLKARE(TM) ADHESIVE REMOVER WIPE
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
510(k) number
K924976
Product code
KOX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-04-20
Date received
1992-10-01
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEVEN R PELTIER
Address
P.O. Box 4000 Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934790SEPP ADHESIVE REMOVERMedi-Flex Hospital Products, Inc.1994-03-11
K931933CHAD LABS ADHESIVE BANDAGE REMOVERChad Labs Corp.1993-07-08
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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