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510(k) K875305

Device
MODEL UCA / SPEC SYSTEM UCA
Applicant
SPEC SYSTEMS, INC.
510(k) number
K875305
Product code
FZH  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-27
Date received
1987-12-29
Regulation
878.5070
Classification name
Apparatus, Air Handling, Room
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEWIS D MITCHELL
Address
P.O. Box 644 701 Lake Dr. Kernersville NC US 27285 27285

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923233CARDIO-PAK LAPAROTOMY PACKCardio-Med-Associates, Inc.1993-03-20
K871901ULTRAFLOWCustom Industries, Inc.1987-06-01
K770084OPERATING ROOM VENTILATORDupaco, Inc.1977-02-23

Legacy Summary#

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FDA Review#

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