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510(k) K003305

Device
PEDIATRIC INGESTASCAN
Applicant
ADAMS ELECTRONICS, INC.
510(k) number
K003305
Product code
HPM  
Decision
Substantially Equivalent (SESE)
Decision date
2000-12-22
Date received
2000-10-20
Regulation
886.4400
Classification name
Locator, Metal, Electronic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT E ADAMS
Address
110 A Sunset Plz. Pmb 311 Enid OK US 73703 73703

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
K953277SHADOW MEDAL LOCATORFatswith Intl., Inc.1996-04-01
K911886PMT METAL LOCATOR, MODEL 3630-1Pmt Corp.1991-08-12
K781892LOCATOR, FOREIGN BODYKeeler Optical Products , Ltd.1978-12-04

Legacy Summary#

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FDA Review#

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