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510(k) K953277

Device
SHADOW MEDAL LOCATOR
Applicant
FATSWITH INTL., INC.
510(k) number
K953277
Product code
HPM  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-01
Date received
1995-07-13
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
HAROLD BERGMAN
Address
2370 Maple St. Vancouver, Bc, CA V6J 3T6 V6J 3T6

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
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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