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510(k) K792106

Device
CONPHAR O.R. HEAD COVER-STERILE
Applicant
CONPHAR, INC.
510(k) number
K792106
Product code
FYI  
Decision
Substantially Equivalent (SESE)
Decision date
1979-11-05
Date received
1979-10-25
Regulation
878.3250
Classification name
Appliance, Facial Fracture, External
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FYI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871073OMEGA BIVALVE NASAL SPLINTSOmega Silicone, Inc.1987-05-11
K821178ETHICON EXTERNAL FIXATION WIREETHICON, Inc.1983-06-11
K801072STRAITH NASAL SPLINTSurgical Technology Laboratories, Inc.1980-06-17

Legacy Summary#

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FDA Review#

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