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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K945328
Device Name JPI X-RAY FILM CASSETTE
Applicant
Jpi America, Inc.
41-02 Bell Blvd.
Suite Ll3
Bayside,  NY  11361
Applicant Contact KI M LEE
Correspondent
Jpi America, Inc.
41-02 Bell Blvd.
Suite Ll3
Bayside,  NY  11361
Correspondent Contact KI M LEE
Regulation Number892.1850
Classification Product Code
IXA  
Date Received11/01/1994
Decision Date 01/20/1995
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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