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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K896707
Device Name PERLINK SCREEN, KIRAN SCREEN
Applicant
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Applicant Contact SUSHIL K KANWAR
Correspondent
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Correspondent Contact SUSHIL K KANWAR
Regulation Number892.1960
Classification Product Code
EAM  
Date Received11/28/1989
Decision Date 08/30/1990
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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