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510(k) K972123

Device
Protective Restraint Models #302,440,750,850,and905
Applicant
SMITH
510(k) number
K972123
Product code
FMQ
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-25
Date received
1997-06-05
Regulation
880.6760
Classification name
Restraint, Protective
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
E.J. Smith
Address
P.O. Box 4341 Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FMQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.2011-04-25
K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.2009-02-13
K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.2008-08-28
K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.2001-11-20
K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.2001-05-24
K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.2001-05-18
K991591BIOTHANE PATIENT RESTRAINTBioplastics1999-07-29
K982178VAGABOND SOFT RESTRAINT SYSTEMEmergent Innovations, Ltd.1999-01-26
K980640HEELBO WAIST AND CHEST VESTHeelbo, Inc.1998-05-01
K972446PEDO CUSH PEDO CUDDLECavity Free Kids, Inc.1997-11-13
K972046FULL BODY RESTRAINT SYSTEMGillen Industries1997-08-15
K971948PATIENT RESTRAINTE.M. Adams Co., Inc.1997-08-06
K971742DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINTDepuy, Inc.1997-07-24
K972338PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.Geriatric Products, Inc.1997-07-24
K971561PROVEST-PROTECTIVE RESTRAINTJemm Medical Products1997-07-14