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510(k) K952561

Device
WATER JEL BURN KIT
Applicant
WATER-JEL TECHNOLOGIES, INC.
510(k) number
K952561
Product code
LRR  
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-14
Date received
1995-06-02
Regulation
510(k) Premarket Notification
Classification name
First Aid Kit With Drug
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
N
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CORNELIA DAMSKY
Address
243 Veterans Blvd. Carlstadt NJ US 07072 07072

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964029EMERGENCY RELIEF KIT SYSTEMBaxter Healthcare Corp1997-03-17
K940249CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSINGCertified Safety Mfg., Inc.1994-10-03
K941311FIRST AID/TRUMA KITCertified Safety Mfg., Inc.1994-06-14
K931058TICK-ATTACK(TM) KITMind Mechanics, Inc.1994-03-01
K931634VARIOUS KITSPolymint Industrial Co. , Ltd.1993-11-30
K921762SHAWNEE PRODUCTS KIT IAbsentee Shawnee Bandage Group1993-01-06
K903393AUTO FIRST-AID KIT FOR AMERICAHisler-Radke, Inc.1991-01-31
K896413COMBINATION 6X-MAGNIFIER AND TWEEZERSJames Alexander Corp.1990-02-01
K895767ORIGINAL TICK KIT/1ST AID KITTick Kit, Inc.1989-12-22
K891483FIRST AID SURVIVAL KITElwyn, Inc.1989-05-11
K871376FIRST AID KIT, VARIOUS SIZESFraass Survival Systems, Inc.1987-06-04
K871501KIT, FIRST AID, GENERAL PURPOSE, RIGID CASEFraass Survival Systems, Inc.1987-06-02
K871457FIRST AID KIT, EYE DRESSINGFraass Survival Systems, Inc.1987-05-29
K841900FIRST RESPONSE EMERG. EYE INJURIESReed Products, Inc.1984-07-23

Legacy Summary#

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FDA Review#

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