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510(k) K862115

Device
DEKNA BAND KIT
Applicant
DEKNATEL, INC.
510(k) number
K862115
Product code
ITG  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-19
Date received
1986-06-03
Regulation
890.3025
Classification name
Bandage, Cast
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
OROFINO
Address
2300 Marcus Ave. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ITG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873111CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.1987-10-09
K842573T.P.G. CAST TAPEThe Poly Group, Inc.1984-08-10
K840416HEXCELITEHexcel Medical1984-03-23
K833732NON WETTING UNDERCAST PADDINGAmerican Medical Disposable, Inc.1983-12-12
K832992SOFFBAN ORTHOPEDIC PADDINGSmith & Nephew, Inc.1983-11-14
K832237ORTHOPEDIC CASTING TAPE MAXCASTCutter Laboratories, Inc.1983-08-16
K830650SUPPORT PRODUCTS EXAMPLE PROSET CASTIsopedix Corp.1983-07-07
K831492YESONA PLASTER OF PARIS BANDAGEWatson Phillips Y Cia. Sucs., S.A. DE C.V.1983-06-30
K820890URETHANE ORTHOPAEDIC CASTING TAPEHexcel Medical1982-06-23
K820140WEBRIL CAST PADDINGStan-Pak Ent.1982-02-12
K820155SPECIALIST CAST PADDINGStan-Pak Ent.1982-02-12
K813052ULTRACAST WATERLESS SYNTHETIC RESIN CASTZimmer, Inc.1982-02-04
K813219CARAFLEX ELASTIC POLYMER PLASTER BANDACarapace, Inc.1981-12-17
K811754CRYSTONASmith & Nephew, Inc.1981-07-20
K811164URETHANE ORTHOPAEDIC CASTING TAPEHexcel Medical1981-05-27

Legacy Summary#

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FDA Review#

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