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510(k) K871901

Device
ULTRAFLOW
Applicant
CUSTOM INDUSTRIES, INC.
510(k) number
K871901
Product code
FZH  
Decision
Substantially Equivalent (SESE)
Decision date
1987-06-01
Date received
1987-05-15
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
JERRY C LAMBERT
Address
6106 W. Market St. P.O. Box 18547 Greensboro NC US 27409 27409

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
K875305MODEL UCA / SPEC SYSTEM UCASpec Systems, Inc.1988-01-27
K770084OPERATING ROOM VENTILATORDupaco, Inc.1977-02-23

Legacy Summary#

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FDA Review#

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