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510(k) K871073

Device
OMEGA BIVALVE NASAL SPLINTS
Applicant
OMEGA SILICONE, INC.
510(k) number
K871073
Product code
FYI  
Decision
Substantially Equivalent (SESE)
Decision date
1987-05-11
Date received
1987-03-18
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#

Contact
OLE JOHANSSON
Address
725 Yanonali Santa Barbara CA US 93103 93103

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
K821178ETHICON EXTERNAL FIXATION WIREETHICON, Inc.1983-06-11
K801072STRAITH NASAL SPLINTSurgical Technology Laboratories, Inc.1980-06-17
K792106CONPHAR O.R. HEAD COVER-STERILEConphar, Inc.1979-11-05

Legacy Summary#

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FDA Review#

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