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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, multi format, radiological
510(k) Number K860761
Device Name MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06
Applicant
LENZAR OPTICS CORP.
1006 W 15TH ST.
RIVIERA BEACH,  FL  33404
Applicant Contact RUSSELL E POPE
Correspondent
LENZAR OPTICS CORP.
1006 W 15TH ST.
RIVIERA BEACH,  FL  33404
Correspondent Contact RUSSELL E POPE
Regulation Number892.2040
Classification Product Code
LMC  
Date Received02/28/1986
Decision Date 04/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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