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510(k) K903946

Device
COOL CAST(R)
Applicant
HAWTHORNE PRODUCTS, INC.
510(k) number
K903946
Product code
LGF  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-31
Date received
1990-08-27
Regulation
888.5940
Classification name
Component, Cast
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DON R HOBSON
Address
Box 66, R.D. #2 Dunkirk IN US 47336 47336

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LGF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K043526SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATICNoble Fiber Technologies, Inc.2005-03-10
K973420CLINITEX CAST PADDINGClinitex Medical Corp.1997-12-09
K973417CLINITEX STOCKINETTEClinitex Medical Corp.1997-12-09
K955320PROTEC COTTON PADDING BANDAGEDerivadas Degasa S.A. DE C.V.1996-01-26
K932507QUICK-CAST IMMOBILIZERLandec Corp.1994-02-23
K931672CARAPACE STERILE CAST PADDINGCarapace, Inc.1993-12-15
K910274ARTIFLEX(TM)Beiersdorf, Inc.1991-03-05
K896634CARAGLAS XTRA SYNTHETIC CASTING TAPEBuckman Co., Inc.1990-06-14
K883294SYNTHETIC CAST TAPECarapace, Inc.1988-08-30
K874880COLORED CASTING TAPE CARAGLAS(TM GREENSynthetic Mfg., Inc.1987-12-30
K873722PEDESTAL WALKING HEEL PRODUCT NO. 4183-133Martin Medical1987-10-02
K873718CHILD WALKING HEEL PRODUCT NO. 4183-132Martin Medical1987-10-02
K873717CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135Martin Medical1987-10-02
K870404COLORED CASTING TAPE (RED AND BLUE)Buckman Co., Inc.1987-02-13
K864092OEC DESIGN ORTHOPEDIC CAST HEELMilitary Engineering, Inc.1986-12-16

Legacy Summary#

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FDA Review#

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