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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K870039
Device Name IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM
Applicant
PAR MICROSYSTEMS CORP.
220 SENECA TURNPIKE
NEW HARTFORD,  NY  13413
Applicant Contact JAMES L CAMBIER,PHD
Correspondent
PAR MICROSYSTEMS CORP.
220 SENECA TURNPIKE
NEW HARTFORD,  NY  13413
Correspondent Contact JAMES L CAMBIER,PHD
Regulation Number870.2810
Classification Product Code
DSF  
Date Received01/05/1987
Decision Date 02/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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