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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K844132
Device Name MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER
Applicant
Sigma Teleproducts, Inc.
200 Oser Ave.
Hauppauge,  NY  11788
Applicant Contact HARVEY SCHWARTZ
Correspondent
Sigma Teleproducts, Inc.
200 Oser Ave.
Hauppauge,  NY  11788
Correspondent Contact HARVEY SCHWARTZ
Regulation Number892.2010
Classification Product Code
LMB  
Date Received10/23/1984
Decision Date 01/22/1985
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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