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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K941224
Device Name LENZAR REMOTE ACQUISITION SYSTEM
Applicant
Lenzar Electrooptics, Inc.
1006 W. 15th St.
Riviera Beach,  FL  33404
Applicant Contact HAROLD BEARDEN
Correspondent
Lenzar Electrooptics, Inc.
1006 W. 15th St.
Riviera Beach,  FL  33404
Correspondent Contact HAROLD BEARDEN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/14/1994
Decision Date 12/09/1994
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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