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510(k) K781892

Device
LOCATOR, FOREIGN BODY
Applicant
KEELER OPTICAL PRODUCTS LTD.
510(k) number
K781892
Product code
HPM  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-04
Date received
1978-11-08
Regulation
886.4400
Classification name
Locator, Metal, Electronic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003305PEDIATRIC INGESTASCANAdams Electronics, Inc.2000-12-22
K953277SHADOW MEDAL LOCATORFatswith Intl., Inc.1996-04-01
K911886PMT METAL LOCATOR, MODEL 3630-1Pmt Corp.1991-08-12

Legacy Summary#

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FDA Review#

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