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510(k) K823737

Device
MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT
Applicant
GOTFRIED MEDICAL, INC.
510(k) number
K823737
Product code
DWL  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-12
Date received
1982-12-13
Regulation
880.5780
Classification name
Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141127MEDLINE ANTI-EMBOLISM STOCKINGMedline Industries, Inc.2014-08-21
K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)Bsn Medical, Inc.2013-07-10
K122485ENCIRCLE COMPRESSION THERAPY STOCKINGEncircle Medical Devices , Ltd.2013-04-23
K123820BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOSBossong Hosiery Mills, Inc.2013-04-02
K123085FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE3M Company2012-12-20
K123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESSBsn Medical, Inc.2012-12-18
K123398DR. SCHOLL'S COMPRESSION SOCKSRenfro Corporation2012-12-18
K121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLETSurgical Appliance Industries, Inc.2012-04-27
K112769CURAD COMPRESSION HOSIERYMedline Industries, Inc.2012-03-01
K111662VENOTRAIN CURAFLOWBauerfeind AG2011-10-04
K101614HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809Dm Systems, Incorporated2011-01-13
K101224SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGSGriffiths and Nielsen, Ltd.2010-12-03
K101906SHAPE TO FIT COMPRESSION WEARTsung Hau Technology Co., Ltd.2010-09-17
K0928921-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613I-Ming Sanitary Materials Co., Ltd.2010-08-03
K090921ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02Beiersdorf, Inc.2009-12-18

Legacy Summary#

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FDA Review#

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