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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K972520
Device Name OPTIVIEW
Applicant
Optimed Technologies, Inc.
293 Eisenhower Pkwy.
Livingston,  NJ  07039
Applicant Contact MOSHE ZCHUT
Correspondent
Optimed Technologies, Inc.
293 Eisenhower Pkwy.
Livingston,  NJ  07039
Correspondent Contact MOSHE ZCHUT
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LMB  
Date Received07/07/1997
Decision Date 09/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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