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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K002404
Device Name MICRO-MAX, MODEL 319
Applicant
Tek Marketing, Inc.
98 Railroad Dr.
Warminster,  PA  18974 -1454
Applicant Contact JOHN A HOPE
Correspondent
Tek Marketing, Inc.
98 Railroad Dr.
Warminster,  PA  18974 -1454
Correspondent Contact JOHN A HOPE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received08/07/2000
Decision Date 08/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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