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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Metal, Electronic
510(k) Number K003305
FOIA Releasable 510(k) K003305
Device Name PEDIATRIC INGESTASCAN
Applicant
Adams Electronics, Inc.
110 A Sunset Plaza
Pmb 311
Enid,  OK  73703
Applicant Contact ROBERT E ADAMS
Correspondent
Adams Electronics, Inc.
110 A Sunset Plaza
Pmb 311
Enid,  OK  73703
Correspondent Contact ROBERT E ADAMS
Regulation Number886.4400
Classification Product Code
HPM  
Date Received10/20/2000
Decision Date 12/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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