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510(k) K060986

Device
HEAD BED
Applicant
Steven H. Warnock, M.D.
510(k) number
K060986
Product code
FRP
Decision
Substantially Equivalent (SESE)
Decision date
2006-07-11
Date received
2006-04-10
Regulation
880.5680
Classification name
Holder, Infant Position
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
STEVEN H WARNOCK
Address
9829 S. 1300 E., Suite 200 Sandy UT US 84094 84094

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K943017NEONATAL RESTRAINT AND COMFORT SYSTEMSK.Bowmed, Inc.1995-01-19
K932636THE TUCKER SLINGTucker Designs, Ltd.1994-01-26
K905629PEDICRAFT INFANT REFLUX WEDGEPedicraft, Inc.1991-03-13
K905630INFANT REFLUX SLINGPedicraft, Inc.1991-03-13
K882544CUDDLE UP PILLOWOhio Medical Instrument Co., Inc.1989-01-31
K844176PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADSPremie Comfort Products1985-01-23
K810609PEDIATRIC POSITION HOLDERKaye Products, Inc.1981-03-20