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510(k) K954216

Device
OLYMPIC WARM-BASSINET
Applicant
OLYMPIC MEDICAL CORP.
510(k) number
K954216
Product code
FOH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-12-08
Date received
1995-09-06
Regulation
880.5560
Classification name
Mattress, Water, Temperature Regulated
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH P STEFANILE
Address
5900 First Ave. S. Seattle WA US 98108 98108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872876IMSI/EASY FLOAT MATTRESSIntl. Management Services, Inc.1987-10-13
K812683NEONATE FLEXFLOATPharmaquest Corp.1981-10-13
K812681ADULT FLEX FLOAT W/HEATERPharmaquest Corp.1981-10-08
K812682FLEXFLOAT HEATERPharmaquest Corp.1981-10-08
K812684ADULT FLEXFLOATPharmaquest Corp.1981-10-08

Legacy Summary#

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FDA Review#

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