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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K992794
Device Name STINGRAY DR, MODEL 1
Applicant
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact RALPH FLATAU
Correspondent
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact RALPH FLATAU
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/19/1999
Decision Date 11/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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