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510(k) K800089

Device
CRAWFORD LACRIMAL INTUBATION SET
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K800089
Product code
HNL  
Decision
Substantially Equivalent (SESE)
Decision date
1980-03-03
Date received
1980-01-14
Regulation
886.4350
Classification name
Probe, Lachrymal
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843491CONCEPT FIBER OPTIC CANALICULUS INTUBAConcept, Inc.1984-10-05
K840861TSE-ANDERSON MODIFIED LACRIMAL GROOVHansen Ophthalmic Development Lab1984-05-09
K833671STERILE OIL AND GUIDEWIRECooperVision, Inc.1984-01-10
K831901LACIMAL INTUBATION SETSVisitec Co.1983-07-12
K813187PILLING LACRIMAL INTUBATION SYSTEMNarco Scientific1982-01-28
K812255ETHICON LACRIMAL STENTETHICON, Inc.1981-08-20
K802845CONCEPT CANALICULUS INTUBATION SETConcept, Inc.1980-12-17
K801232JACKSON LACRIMAL INTUBATION SETStorz Instrument Co.1980-06-17
K770194NASO-LACRIMAL DUCT INSERTConcept, Inc.1977-02-14

Legacy Summary#

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FDA Review#

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