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510(k) K853600

Device
INFLATABLE AIR SPLINTS
Applicant
HOSPITAK, INC.
510(k) number
K853600
Product code
FZF  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-19
Date received
1985-08-27
Regulation
878.3900
Classification name
Splint, Extremity, Inflatable, External
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM J LACEY
Address
1144 Rte. 109 Lindenhurst NY US 11757 11757

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881516COMPRESAIDR. Evans Corp.1988-04-29
K874050INFLATABLE FOOT & ANKLE SPLINTVinyl Technology, Inc.1987-11-23
K874051INFLATABLE FULL LEG SPLINTVinyl Technology, Inc.1987-11-23
K874052INFLATABLE HALF LEG SPLINTVinyl Technology, Inc.1987-11-23
K874053INFLATABLE FULL ARM SPLINTVinyl Technology, Inc.1987-11-23
K831764URIAS PRESSURE SPLINTS, & FIRST AIDSvenol Andersen1983-09-12

Legacy Summary#

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FDA Review#

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