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510(k) K841002

Device
LACHRYMAL PROBES-VARIOUS
Applicant
PREMIER DENTAL PRODUCTS CO.
510(k) number
K841002
Product code
HNW  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-09
Date received
1984-03-09
Regulation
886.4350
Classification name
Dilator, 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 HNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862070INTER-SHARPIntermedics Intraocular, Inc.1986-06-17
K812097KOI LACREMAL HOOK & DILATORKoi, Inc.1981-08-18

Legacy Summary#

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FDA Review#

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