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510(k) K923233

Device
CARDIO-PAK LAPAROTOMY PACK
Applicant
CARDIO-MED-ASSOCIATES, INC.
510(k) number
K923233
Product code
FZH  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1993-03-20
Date received
1992-07-01
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
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEROME E DERNBACH
Address
1602 4th Ave. N. Billings MT US 59101 59101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FZH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K875305MODEL UCA / SPEC SYSTEM UCASpec Systems, Inc.1988-01-27
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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