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510(k) K830871

Device
PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
Applicant
PHAKOSYSTEMS, INC.
510(k) number
K830871
Product code
HOC  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-02
Date received
1983-03-18
Regulation
886.4350
Classification name
Clip, Iris Retractor
Medical specialty
Ophthalmic
Review panel
Ophthalmic
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 HOC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871474PART #860070 ULTRAPAK & #860075 ULTRAPAKMedical Technical Products1987-08-10

Legacy Summary#

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FDA Review#

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