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510(k) K911132

Device
MULTIPLE, SURGICAL DRAPE PACK
Applicant
CENTRAL GEORGIA ANCILLARY HEALTH SYSTEMS
510(k) number
K911132
Product code
FZI  
Decision
Substantially Equivalent (SESE)
Decision date
1991-05-06
Date received
1991-03-14
Regulation
878.5070
Classification name
Apparatus, Air Handling, Enclosure
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JACK HERNDON
Address
4269 Interstate Pkwy. Macon GA US 31204 31204

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K910468STERILE DISPOSABLE DRAPE(S)E.M. Adams1991-03-21
K854159ELLIPTI-PUNCHAlcon Laboratories1985-11-15
K772394KALRN FACE-LIFE SCISSORSEdward Weck, Inc.1978-03-09
K772395DAVIS RHYTIDECTOMYEdward Weck, Inc.1978-03-09

Legacy Summary#

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FDA Review#

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