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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 K930244
Device Name JPI X-RAY FILM CASSETTE
Applicant
Jpi, Inc.
350-J Central Ave.
Bohemia,  NY  11716
Applicant Contact WILIAM HAGUE
Correspondent
Jpi, Inc.
350-J Central Ave.
Bohemia,  NY  11716
Correspondent Contact WILIAM HAGUE
Regulation Number892.1850
Classification Product Code
IXA  
Date Received01/19/1993
Decision Date 04/07/1993
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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